Clinical trials
SWEET
Identifier
NCT04873050
Link
https://clinicaltrials.gov/study/NCT04873050
Phase
Marketed
Status
Recruiting
Sponsor
Woman's
More details
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.
Purpose
Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
Interventions
Intervention 1
Semaglutide Pen Injector [Ozempic]
Intervention 2
Placebo semaglutide pen injector
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-01-13
Anticipated Date of Last Follow-up
2025-03-10
Estimated Primary Completion Date
2026-01-01
Estimated Completion Date
2026-03-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Female
2. 18 - 45 years old (inclusive)
3. History of gestational diabetes in most recent pregnancy
4. 6 months - 10 years postpartum
5. BMI ≥ 25 kg/m2
6. Use of long-acting reversible contraception or bilateral tubal ligation
7. Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
1. Fasting glucose 100-125mg/dL (inclusive) and/or
2. 120 minute glucose 140-199mg/dL (inclusive)
8. Willingness to maintain physical activity level throughout study duration
9. Willingness to standardize diet for 3 days prior to OGTT
10. Ability to provide informed consent before any trial-related activities
Exclusion Criteria:
1. Body weight \> 350lb
2. Pregnant or the int
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
102
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
852967
Identifier
NCT05746039
Link
https://clinicaltrials.gov/study/NCT05746039
Phase
Phase I/II
Status
Recruiting
Sponsor
University of Pennsylvania
More details
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.
The main question\[s\] it aims to answer are:
1. Are patients with advanced lung disease able to tolerate semaglutide therapy?
2. Are we able to titrate semaglutide therapy to a target weight?
Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
Purpose
Feasibility of Semaglutide in Advanced Lung Disease
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-01-29
Anticipated Date of Last Follow-up
2025-03-13
Estimated Primary Completion Date
2025-12-28
Estimated Completion Date
2025-12-28
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension
* Age \> 18
* BMI \> 30 kg/m2
* Requires supplemental oxygen on exertion
* Stable treatment regimen X 90 days
* Use of disease-modifying therapy
Exclusion Criteria:
* Diabetes
* Pregnant or Breastfeeding
* Recent weight loss
* Recent or chronic GI complaints
* History of gastroparesis
* History of scleroderma
* Hospitalized at time of evaluation
* Use of weight loss medication in last 90 days
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2)
* Uncontrolled thyroid disease
* History of acute/chronic pancreatitis
* Prior suicide attempt
* Suicidal ideation in last 90 d
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
8
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SEMA-VR
Identifier
NCT05870462
Link
https://clinicaltrials.gov/study/NCT05870462
Phase
Marketed
Status
Unknown status
Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
More details
SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized (1:1) to receive semaglutide at escalating doses (up to 1.0 mg/week) or usual care without semaglutide for 6 months.
The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is:
• Does semaglutide treatment preserve or increase the number of vessel-repairing cells circulating in the blood?
Participants will:
* Be allocated to receive either semaglutide or usual care for 6 months
* Provide a blood sample at the baseline visit and another blood sample at the 6-month visit
Researchers will compare participa
Purpose
Semaglutide and Vascular Regeneration
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
Canada
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-04-29
Anticipated Date of Last Follow-up
2023-07-22
Estimated Primary Completion Date
2024-12-01
Estimated Completion Date
2024-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Adults ≥ 18 years of age who meet one of the following Health Canada indications to receive subcutaneous semaglutide injections:
* Documented T2D with inadequate glycemic control
* Body mass index (BMI) ≥ 30 kg/m\^2 (obesity)
* BMI ≥ 27 kg/m\^2 (overweight) and at least one weight-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea
2. AND meet one of the following ASCVD criteria:
* History of ASCVD:
* Documented coronary artery disease
* Documented cerebrovascular or carotid disease
* Documented peripheral artery disease
* No ASCVD but has 2 or more of the following risk factors:
* Cigarette smoker or stopped smoking within 3 months of screening
* Persistent hypertension (defined as office b
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
100
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SIB
Identifier
NCT04979130
Link
https://clinicaltrials.gov/study/NCT04979130
Phase
Marketed
Status
Completed
Sponsor
University of Colorado, Denver
More details
This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.
Purpose
Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-01-01
Anticipated Date of Last Follow-up
2025-03-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-10-16
Actual Completion Date
2024-10-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial, except for protocol described pre-screening activities, which require a separate informed consent.
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus on metformin monotherapy
4. Hemoglobin A1c \<8.0% (\<64 mmol/mol) on screening day
5. Body mass index (BMI) ≥28 kg/m2
6. Low-grade inflammation, defined as elevated high sensitivity C-reactive protein (hs- CRP \>1.0 and ≤10 mg/L). Impaired intestinal barrier function results in activation of inflammatory pathway; therefore, exclud
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
69
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
07125
Identifier
NCT05249881
Link
https://clinicaltrials.gov/study/NCT05249881
Phase
Pre-clinical
Status
Unknown status
Sponsor
Aga Khan University
More details
A prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. Selected parameters will be measured at baseline and after the 12 weeks of therapy. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.
From this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight GLP-1 naive patients.
Purpose
"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-10
Anticipated Date of Last Follow-up
2022-08-03
Estimated Primary Completion Date
2022-12-01
Estimated Completion Date
2022-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Both male and female Type 2 Diabetic patients with age ≥18 years.
* Patients with HbA1c ≥ 7.5 % - ≤ 10.0%
* Patients with BMI ≥ 30
Exclusion Criteria:
* Patients with Type 1 Diabetes Mellitus
* Patients with Gestational Diabetes Mellitus.
* Patients with Chronic Renal Failure with eGFR of ≤ 30ml/min
* Patient already on another GLP 1 analogue
* The patient stopped any GLP1 analogue treatment less than 3 months back.
* Patients with history of chronic pancreatitis or pancreatic cancer.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
300
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STUDY00005760
Identifier
NCT05302596
Link
https://clinicaltrials.gov/study/NCT05302596
Phase
Phase II
Status
Completed
Sponsor
State University of New York at Buffalo
More details
This is a single-center, prospective, controlled, randomized and open label study to investigate the effect of the semaglutide addition to standard of care weight loss intervention (personalized lifestyle and exercise) in elderly obese subjects on body weight and body composition as assessed by DEXA.
Purpose
Semaglutide Use in Elderly Obese Patients
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-09-01
Anticipated Date of Last Follow-up
2025-03-31
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-23
Actual Completion Date
2024-10-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Males and females age: ≥65 years
2. BMI ≥30 Kg/m2 AND waist circumference for women: \> 80 cm and for men: \> 90 cm
3. Stable body weight (no more than ±3 kg change during the 3 months prior to screening)
4. Able to participate in personalized physical activities and dietary instructions.
5. Participant must be able to read, write, and understand the English language and be able to provide written consent.
Exclusion Criteria:
1. Current diagnosis of weight changing condition including cancer, gastrointestinal conditions or eating disorders
2. GLP-1R agonists use within last 6 months
3. Diagnosis of type 1 or 2 diabetes
4. Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤ 19)
5. History of chronic/idiopathic acute pancreatitis
6.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
16
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
LYG2022061
Identifier
NCT06149260
Link
https://clinicaltrials.gov/study/NCT06149260
Phase
Phase I
Status
Recruiting
Sponsor
Second Xiangya Hospital of Central South University
More details
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Purpose
Subcutaneous Semaglutide in Systemic Scleroderma
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-02-29
Anticipated Date of Last Follow-up
2024-03-02
Estimated Primary Completion Date
2024-08-29
Estimated Completion Date
2024-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:(Those who have not achieved good results after hormone or immunosuppressive therapy)
1. Gender unlimited;
2. Age 18-65 years old (including 65 years old);
3. Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.
4. Has received one or more of the following standard systemic treatments allowed by the research protocol:
1. Before the first subcutaneous injection of the study, oral corticosteroids (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks, and stabilizers were administered for ≥ 4 weeks.
2. Before the first subcutaneous injection of the study, pat
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
10
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
PORT
Identifier
NCT05071898
Link
https://clinicaltrials.gov/study/NCT05071898
Phase
Phase I
Status
Recruiting
Sponsor
University of Maryland, Baltimore
More details
Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims:
1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug).
2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of dru
Purpose
Pharmacogenetics of Response to GLP1R Agonists
Interventions
Intervention 1
Semaglutide Pen Injector [Ozempic]
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-04-11
Anticipated Date of Last Follow-up
2025-06-26
Estimated Primary Completion Date
2026-11-30
Estimated Completion Date
2027-12-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* BMI greater than or equal to 27 kg/m2
* Of Amish Descent
Exclusion Criteria:
* Woman of childbearing age who is sexually active
* History of diabetes (HbA1c \> 6.5% or random glucose \>200 mg/dL)
* Known allergy to semaglutide
* Medical issues, which in the judgment of the research physician or PIs might increase the risk associated with participation in the study
* eGFR \< 60 mL/min/1.73 sq. m.
* Hematocrit \< 35%
* TSH \< 0.4 o4 \> 5.5
* AST or ALT in excess of 2X the upper limit of normal
* Unable to discontinue a drug, vitamin, or nutritional supplement, which in the judgment of the research physician or PIs might alter the response to semaglutide
* Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
600
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
QLG2065-301
Identifier
NCT05950516
Link
https://clinicaltrials.gov/study/NCT05950516
Phase
Phase III
Status
Unknown status
Sponsor
Qilu Pharmaceutical Co., Ltd.
More details
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.
Purpose
Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
Interventions
Intervention 1
Semaglutide
Intervention 2
Semaglutide Pen Injector [Ozempic]
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2023-07-10
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2023-07-11
Estimated Primary Completion Date
2024-11-24
Estimated Completion Date
2025-01-22
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
2. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
3. Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses;
4. At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%（local lab）; for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%（local la
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
478
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
GAINPCCONTROL
Identifier
NCT06908694
Link
https://clinicaltrials.gov/study/NCT06908694
Phase
Marketed
Status
Recruiting
Sponsor
Hamilton Health Sciences Corporation
More details
GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.
Purpose
Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy
Interventions
Intervention 1
Semaglutide Pen Injector
Countries
Canada
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-07-02
Anticipated Date of Last Follow-up
2025-07-25
Estimated Primary Completion Date
2026-07-31
Estimated Completion Date
2026-07-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have a physician diagnosis of PC
* Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)
* Elevated BMI
1. ≥30kg/m2 or
2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia
Exclusion Criteria:
* Type 1 diabetes
* Taking a GLP-1 RA
* \<18 years of age
* History of pancreatitis
* Personal or family history of medullary cancer of the thyroid
* Multiple endocrine neoplasia type 2
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
20
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SERENA
Identifier
NCT05569772
Link
https://clinicaltrials.gov/study/NCT05569772
Phase
Phase III
Status
Recruiting
Sponsor
Universitaire Ziekenhuizen KU Leuven
More details
Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, the investigators aim to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.
Purpose
Semaglutide for the Treatment of Glucose Intolerance in Women with Prior Gestational Diabetes
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Semaglutide placebo
Countries
Belgium
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-09-14
Anticipated Date of Last Follow-up
2025-02-06
Estimated Primary Completion Date
2028-07-01
Estimated Completion Date
2028-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control
3. History of GDM (diagnosed with 2013 WHO criteria 24-32 weeks of pregnancy) and glucose intolerance 6-24 weeks postpartum (based on the ADA criteria)
4. Needs to be able to understand and speak Dutch, French or English
Exclusion Criteria:
* 1\. Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes, history of pancreatitis, family or personal history of medullary thyroid carcinoma or personal history of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, severe psychiatric disorder in the past year, heart failure NYHA class 4, end-stage renal disease (eGFR \<
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
252
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
T1-DISCO
Identifier
NCT05819138
Link
https://clinicaltrials.gov/study/NCT05819138
Phase
Phase III
Status
Recruiting
Sponsor
University of Colorado, Denver
More details
This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.
Purpose
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-06-21
Anticipated Date of Last Follow-up
2025-05-30
Estimated Primary Completion Date
2027-10-01
Estimated Completion Date
2027-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Age 18-49 years
* 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
* Insulin pump or automated insulin delivery systems
* Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
* Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
* BMI 20-45 kg/m2
* Adequate contraceptive method for females
Exclusion Criteria:
* HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
* Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
* History/family history of medullary thyroid carcinoma, multip
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
60
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
PROTECT
Identifier
NCT06449625
Link
https://clinicaltrials.gov/study/NCT06449625
Phase
Phase II
Status
Not yet recruiting
Sponsor
Klaus Gottlob Müller
More details
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Study design:
The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3
Purpose
Semaglutide in Auto-HSCT
Interventions
Intervention 1
Semaglutide Pen Injector [Ozempic]
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2024-08-12
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2024-06-03
Estimated Primary Completion Date
2026-12-31
Estimated Completion Date
2027-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
* Age ≥ 18 years
* BMI ≥ 18.5
* ECOG performance status\* ≤ 2
* Literate in Danish and/or English
Exclusion Criteria:
* Diabetes
* Inflammatory bowel disease
* Previous or current gastrointestinal malignancy
* Personal or family history of medullary thyroid carcinoma or MEN syndrome
* Genetic disorders with defective tissue repair (e.g., Fanconi anaemia)
* History of pancreatitis (acute or chronic)
* Renal impairment measured as eGFR value of \< 30 ml/min/1.73 m2
* Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times upper normal limit at screening
* Known or suspected hypersensitivity to semaglutide or other GLP-1RA
* Pregnant or nursing females
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
40
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
2000031181
Identifier
NCT05067621
Link
https://clinicaltrials.gov/study/NCT05067621
Phase
Phase II
Status
Recruiting
Sponsor
Yale University
More details
The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.
Purpose
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-17
Anticipated Date of Last Follow-up
2025-05-15
Estimated Primary Completion Date
2026-12-01
Estimated Completion Date
2027-01-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to \<200 mg/dl post-OGTT OR HbA1c ≥5.7% to \<6.5%), OR new-onset T2D (≤24 months duration, 2h glucose \>200 and HbA1c \>6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less)
* PDFF of ≥ 8%
* Male or female, aged 10 to \<21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study
* Weight ≥ 54kg
* BMI ≥ 85% but ≤
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
60
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STUDY00024676
Identifier
NCT06548490
Link
https://clinicaltrials.gov/study/NCT06548490
Phase
Phase II
Status
Recruiting
Sponsor
Milton S. Hershey Medical Center
More details
The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:
• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?
The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.
The participants will:
* Take semaglutide or a placebo every week for 12 weeks
* Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires
* Comp
Purpose
GLP-1R Agonist Treatment for Opioid Use Disorder
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-01-13
Anticipated Date of Last Follow-up
2025-08-11
Estimated Primary Completion Date
2026-11-01
Estimated Completion Date
2026-11-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Age 18 to 75 years.
* Body mass index (BMI) \> 18.
* Able and willing to provide informed consent prior to any study-related activities.
* Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI \> 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).
* Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an associated clinic at the time of enrollment.
* Have at least 1 urine test positive for opioids aft
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
200
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
HM20024306
Identifier
NCT05424003
Link
https://clinicaltrials.gov/study/NCT05424003
Phase
Phase II
Status
Recruiting
Sponsor
Virginia Commonwealth University
More details
In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.
Purpose
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-02-22
Anticipated Date of Last Follow-up
2025-07-02
Estimated Primary Completion Date
2026-02-01
Estimated Completion Date
2026-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
* Liver transplant surgery within 8-24 weeks prior to randomization
* Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%)
* Ability to provide informed consent
* Discharged from the hospital following LT surgery
* Tolerating diet
* Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate)
* Eligible female patients will be (1) non-pregnant, evidence
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
50
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SEMA
Identifier
NCT05303857
Link
https://clinicaltrials.gov/study/NCT05303857
Phase
Marketed
Status
Completed
Sponsor
University of Erlangen-Nürnberg Medical School
More details
This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of Nephrology and Hypertension, with its two separate locations:
* Nürnberg, Kreuzburger Str. 2, 90471 Nürnberg, and
* Erlangen, Ulmenweg 18, 91054 Erlangen The main goal of the study is to demonstrate the effect of semaglutide on different vascular parameters of the macro- and microcirculation. The primary objective is to analyze the effect of semaglutide, compared to placebo on central (aortic) pulse pressure.
At least 90 patients will be randomized (1:1) and included (informed consent, intention to treat population) in order to obtain 80 fully evaluable subjects (per protocol population).
Patients will be simult
Purpose
Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-03
Anticipated Date of Last Follow-up
2025-06-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-12-15
Actual Completion Date
2025-04-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Age of 18 - 75 years
* Diagnosis of type 2 diabetes mellitus: defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6,5 % or on oral single or dual blood glucose lowering medication (held constant for the last 3 months)
* HbA1c ≥ 7.0%
* Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
* Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
* Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
Exclusion Criteria:
* Any other form of diabetes mellitus than type 2 diabetes mellitus
* Use of insulin, sulfonylurea or GLP-1 analogue within the past 3 months
* Patients with more than two oral blood glucose lo
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
107
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
2000035452
Identifier
NCT06411210
Link
https://clinicaltrials.gov/study/NCT06411210
Phase
Phase II
Status
Recruiting
Sponsor
Yale University
More details
More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.
Purpose
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Placebo
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-07-16
Anticipated Date of Last Follow-up
2025-04-29
Estimated Primary Completion Date
2028-04-30
Estimated Completion Date
2028-06-30
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)
* Clinical diagnosis of T1D
* Diabetes duration diagnosed ≥ 12 months ago
* HbA1c ≤10% at screening and within the past 90 days
* Stable reported insulin dosing in the past 90 days (within 15%)
* Stable reported BMI in the past 90 days (within 5%)
* Ability to provide written informed consent before any trial-related activities
* Use of real-time continuous glucose monitoring and planned continued use
* Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study particip
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
54
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4601
Identifier
NCT04238962
Link
https://clinicaltrials.gov/study/NCT04238962
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clini
Purpose
A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens
Interventions
Intervention 1
Semaglutide (administered by DV3396 pen-injector)
Intervention 2
Semaglutide (administered by PDS290 pen-injector)
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-02-03
Anticipated Date of Last Follow-up
2020-11-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-10-20
Actual Completion Date
2020-10-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Body weight between 65.0 and 130.0 kg (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
* Any disorder which in the investigator's
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
111
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4588
Identifier
NCT04152915
Link
https://clinicaltrials.gov/study/NCT04152915
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. P
Purpose
A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
Interventions
Intervention 1
Semaglutide
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-11-25
Anticipated Date of Last Follow-up
2021-11-09
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-05-25
Actual Completion Date
2020-05-25
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
* Body mass index between 25.0 and 34.9 kg/m\^2 (both inclusive) and
* Body weight between 65.0 and 130.0 kg (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
68
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9536-4475
Identifier
NCT04012255
Link
https://clinicaltrials.gov/study/NCT04012255
Phase
Phase I
Status
Terminated
Sponsor
Novo Nordisk A/S
More details
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Part
Purpose
A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
Interventions
Intervention 1
Semaglutide (administered by DV3396 pen)
Intervention 2
Semaglutide (administered by PDS290 pen)
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-07-15
Anticipated Date of Last Follow-up
2019-10-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-08-30
Actual Completion Date
2019-10-22
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight between 70.0 and 130.0 kg (both inclusive)
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Inability or unwillingness to perform self-injection
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
29
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9536-4590
Identifier
NCT04187300
Link
https://clinicaltrials.gov/study/NCT04187300
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doct
Purpose
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
Interventions
Intervention 1
Semaglutide
Countries
Slovenia
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-12-16
Anticipated Date of Last Follow-up
2021-11-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-09-23
Actual Completion Date
2020-09-23
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight between 70.0 and 130.0 kg (both inclusive)
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Inability or unwillingness to perform self-injection
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
68
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
ENDIS
Identifier
NCT05857085
Link
https://clinicaltrials.gov/study/NCT05857085
Phase
Marketed
Status
Completed
Sponsor
General and Teaching Hospital Celje
More details
The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.
Purpose
Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
Interventions
Intervention 1
Semaglutide Pen Injector [Ozempic]
Intervention 2
Empagliflozin 10 MG
Countries
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-12-15
Anticipated Date of Last Follow-up
2023-05-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-03-10
Actual Completion Date
2023-04-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* T1DM
* HbA1C\<=9%
* prone to CGM system
* 20 - 70 years
Exclusion Criteria:
* HbA1C \>9%,
* BMI\<22,
* pregnancy or lactation,
* known hypersensitivity to study drug,
* malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),
* liver cirrhosis child C,
* eGFR\<60 ml/min,
* chronic inflammatory disease,
* proliferative diabetic rethinopathy,
* MEN or medullary thyroid cancer in familly,
* concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
* Major cardiovascular event last 2 months ( stroke, MI)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
90
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
GP40221-P4-01-01
Identifier
NCT06497049
Link
https://clinicaltrials.gov/study/NCT06497049
Phase
Phase I
Status
Completed
Sponsor
Geropharm
More details
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.
Purpose
Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.
Interventions
Intervention 1
GP40221
Intervention 2
ozempic
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-06-30
Anticipated Date of Last Follow-up
2024-07-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-05-05
Actual Completion Date
2024-05-05
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Signed informed consent to participate in the study.
* Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
* Age 18-45 years old inclusive.
* Body mass index 18.5 - 29.9 kg/m2.
* Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.
* Consent to all restrictions imposed during the study.
* Citizenship of the Russian Federation.
Exclusion Criteria:
* Burdened allergic history, drug intolerance.
* Hypersensitivity to heparin, semaglutide and any of the excipients of the study drug.
* Any acute and chronic diseases, incl. but not limited to:
1. diseases of the cardiovascula
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
120
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4885
Identifier
NCT05232708
Link
https://clinicaltrials.gov/study/NCT05232708
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and
Purpose
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
Interventions
Intervention 1
Semaglutide B, 1.34 mg/mL
Intervention 2
Semaglutide D, 1.0 mg/mL
Intervention 3
Semaglutide D, 1.0 mg/mL
Intervention 4
Semaglutide B, 1.34 mg/mL
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-01-19
Anticipated Date of Last Follow-up
2024-01-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-08-30
Actual Completion Date
2022-08-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Male or female
* Aged 20-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive)
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
* Abuse or intake of alcohol, defined as any o
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
GATA-3
Identifier
NCT05254314
Link
https://clinicaltrials.gov/study/NCT05254314
Phase
Phase II
Status
Recruiting
Sponsor
Vanderbilt University Medical Center
More details
This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity.
Purpose
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Interventions
Intervention 1
Semaglutide Pen Injector 2.4mg weekly
Intervention 2
Placebo
Countries
Denmark
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-10-11
Anticipated Date of Last Follow-up
2025-02-18
Estimated Primary Completion Date
2026-02-01
Estimated Completion Date
2026-04-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. . Subject must be able to understand and provide informed consent.
2. Males and females age 18 or older
3. Obesity defined as body mass index (BMI) \>=30, or \>=27 in the setting of \>=1 weight-related comorbidity:
* clinically documented hypertension (\>130 mmHg systolic or \>85 mmHg diastolic or treatment) in the prior year or during run-in
* clinically documented dyslipidemia (Triglycerides ш 150 mg/dl, HDL \<40 mg/dl in males or \<50 mg/dl in females, \>=130 mg/dl or treatment) in the prior year or during run-in
* current obstructive sleep apnea treatment
* documented pre-diabetes defined by A1c 5.7-\<6.5 in the prior year or during run-in
* clinically documented cardiovascular disease
4. History of physician-diagnosed asthma
5. Persistent Asthma
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
100
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
OBES1TY
Identifier
NCT06909006
Link
https://clinicaltrials.gov/study/NCT06909006
Phase
Phase III
Status
Not yet recruiting
Sponsor
Nordsjaellands Hospital
More details
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
Purpose
Semaglutide Treatment in Type 1 Diabetes
Interventions
Intervention 1
Semaglutide 2.4mg
Intervention 2
Semaglutide placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-10-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-08-04
Estimated Primary Completion Date
2028-06-01
Estimated Completion Date
2028-06-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Type 1 Diabetes for more than 3 years
* BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Exclusion Criteria:
* Treated with GLP1-RAs within last 6 months
* Known intolerance for semaglutide
* Other forms of diabetes
* Pregnant or nursing women
* Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> five times and plasma aspartate aminotransferase (AST) \> five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
* Acute or chronic pancreatit
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
122
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
RAISE-KT
Identifier
NCT04741074
Link
https://clinicaltrials.gov/study/NCT04741074
Phase
Phase III
Status
Terminated
Sponsor
Geisinger Clinic
More details
This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.
Purpose
Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
Interventions
Intervention 1
Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution
Intervention 2
Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-07-23
Anticipated Date of Last Follow-up
2024-02-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-01-31
Actual Completion Date
2023-01-31
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. \- Age ≥ 18 years
2. \- BMI 25-45 kg/m2
3. \- T2DM
4. \- Advanced CKD\* (last eGFR \<30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to \<45 ml/min/1.73m2 with albumin/creatinine ratio \>30 mg/g).
5. \- Fulfill kidney transplant listing criteria except for one or more of the following reasons (1: uncontrolled diabetes \[A1c ≥9%); 2: severe obesity (BMI ≥ 40 kg/m2 or BMI 35-40 kg/m2 with waist circumference \>120 cm). See exclusion criteria for general contraindications used for transplant listing used by majority of U.S. transplant centers\].
6. \- Ability to provide informed consent before any trial-related activities
7. \- Access to a telephone
* The cause of the CKD does not need to be due specifically to diabete
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
15
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9536-4649
Identifier
NCT04228354
Link
https://clinicaltrials.gov/study/NCT04228354
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to b
Purpose
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
Interventions
Intervention 1
Semaglutide
Countries
Canada
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-01-29
Anticipated Date of Last Follow-up
2022-01-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-06-01
Actual Completion Date
2020-06-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 27.0 kg/m\^2 (both inclusive).
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
28
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
JOULE-MARS
Identifier
NCT06852391
Link
https://clinicaltrials.gov/study/NCT06852391
Phase
Marketed
Status
Not yet recruiting
Sponsor
McMaster University
More details
The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the imp
Purpose
JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Interventions
Intervention 1
Semaglutide Pen Injector
Intervention 2
Behavioural Lifestyle Program (BLP)
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-03-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-03-20
Estimated Primary Completion Date
2027-12-31
Estimated Completion Date
2027-12-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Youth aged 12-17 years
* Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median)
* Enrolled in first six months of GHWM pediatric clinic (ie. have at least one year of the program remaining).
Exclusion Criteria:
* Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight \>300lb.
* Use of atypical anti-psychotics.
* Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.)
* Current mental health diagnosis including anxiety or depression or high depressive symptoms (score on
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
74
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SemVLCD
Identifier
NCT05606471
Link
https://clinicaltrials.gov/study/NCT05606471
Phase
Marketed
Status
Unknown status
Sponsor
University of Nottingham
More details
The very-low calorie diet (VLCD) is a highly effective and safe way to rapidly lose significant amounts of weight and dramatically improve blood sugar control in a short period of time (typically 8-12 weeks). It has recently become recommended by the UK National Health Service as a treatment for selected patients with type 2 diabetes. One drawback of VLCD however is the associated loss of skeletal muscle which affects some patients.
Semaglutide is a well-known medication for type 2 diabetes that also improves blood sugar control and facilitates weight loss. Recent research has shown that it may also stimulate muscle growth, meaning it could help to preserve muscle mass during weight loss. Therefore, this research study aims to see whether taking Semaglutide alongside the VLCD reduces the
Purpose
Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets
Interventions
Intervention 1
Semaglutide Pen Injector [Ozempic]
Intervention 2
Very-low Calorie Diet
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-09-15
Anticipated Date of Last Follow-up
2022-10-31
Estimated Primary Completion Date
2023-07-28
Estimated Completion Date
2023-07-28
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Confirmed Type 2 Diabetes Mellitus
* Body mass index \> 27kg·m-2
* Eligible for VLCD, Semaglutide (or both), within routine practice
* Ability to provide informed consent
Exclusion Criteria:
* BMI \> 50kg·m-2
* Current pregnancy or breastfeeding, or intention to fall pregnant within the next 3 months
* Uncontrolled hypertension (blood pressure \>200/120mmHg)
* Current treatment with insulin
* Current or recent use of GLP-1 agonists
* Previous adverse reaction to a GLP-1 agonist
* Current or recent involvement in a VLCD programme (within the last 12 months)
* History of \>5% weight loss within the preceding 12 months
* Ingestion of exogenous D2O within the preceding 12 months
* Background of clinically significant cardiovascular, cerebrovascular or respiratory disea
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
45
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4429
Identifier
NCT03611322
Link
https://clinicaltrials.gov/study/NCT03611322
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
This study compares semaglutide in two different injection tools called "PDS290" and "DV3372". The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools. The researchers also want to look at how well the injection tools work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection tool. This is decided by chance, like flipping a coin. This is called randomisation. Semaglutide is an approved medicine (thus available on the market) for people with type 2 diabetes. Semaglutide will be injected subcutaneously (injection under the skin). Participants will get a total of 5 injections with semaglutide. The study will last for a maximum of 86 days. Participants will have 17 scheduled site visits with the study physi
Purpose
A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide 1 mg by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)
Interventions
Intervention 1
Semaglutide, 0.25 mg
Intervention 2
Semaglutide, 0.5 mg
Intervention 3
Semaglutide, 1.0 mg
Intervention 4
DV3372
Intervention 5
PDS290 pen-injector
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-08
Anticipated Date of Last Follow-up
2020-01-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-01-07
Actual Completion Date
2019-01-07
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria: - Male or female, aged 18 to 55 years (both inclusive) at the time of signing informed consent. - Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive) and weight between 55.0 and 90.0 kg (both inclusive). - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. - Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. - Use o
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
54
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
COMBAT_T2_NASH
Identifier
NCT04639414
Link
https://clinicaltrials.gov/study/NCT04639414
Phase
Marketed
Status
Not provided
Sponsor
German Diabetes Center
More details
The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.
Purpose
Combined Active Treatment in Type 2 Diabetes with NASH
Interventions
Intervention 1
Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector
Intervention 2
Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide
Intervention 3
Placebo matching empagliflozin and placebo pen injector matching semaglutide
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-03-26
Anticipated Date of Last Follow-up
2024-10-08
Estimated Primary Completion Date
2025-01-31
Estimated Completion Date
2025-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Diagnosis of T2D and NASH with fibrosis stage F1-F3
* Age between 25 and 75 years
* HbA1c ≤ 9.5%
* obtained written informed consent
Exclusion Criteria:
* Contraindications on liver biopsy
* Evidence of cirrhosis on liver biopsy
* Liver disease of other etiology including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology
* History of ketoacidosis
* Alcohol consumption \>30 g/d for males and \>20 g/d for females
* Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment
* Medications that
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
192
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STAR-T
Identifier
NCT05891587
Link
https://clinicaltrials.gov/study/NCT05891587
Phase
Phase II
Status
Recruiting
Sponsor
Oklahoma State University Center for Health Sciences
More details
The purpose of this research study is to determine if semaglutide, when compared to placebo, is safe and may reduce alcohol drinking in individuals who endorse symptoms consistent with alcohol use disorder.
Purpose
Semaglutide Therapy for Alcohol Reduction - Tulsa
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-07
Anticipated Date of Last Follow-up
2025-03-17
Estimated Primary Completion Date
2025-07-01
Estimated Completion Date
2025-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Ability to provide informed consent before any trial-related activities
2. Male or female individuals who are at least 18 years old
3. Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., DSM-5 Checklist for Alcohol Use Disorder, the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
4. Self-reported drinking, according to alcohol TimeLine Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males during the 28-day period prior to screening + at least four days with \> 3 drinks for females or \> 4 drinks for males during the 28-day period prior to screening.
5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
80
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SEMINAL-AF
Identifier
NCT06499857
Link
https://clinicaltrials.gov/study/NCT06499857
Phase
Phase III
Status
Recruiting
Sponsor
University of Chicago
More details
The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.
Purpose
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-04-14
Anticipated Date of Last Follow-up
2025-08-01
Estimated Primary Completion Date
2027-12-01
Estimated Completion Date
2028-06-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Age 18-75 years
2. BMI greater than or equal to 30 kg/m2
3. Paroxysmal AF or persistent AF, in whom catheter ablation (CA) for AF is expected within 1 year (A group) or in whom catheter ablation is NOT expected within 1 year (M group)
4. Ability to provide informed consent before any trial-related activities.
5. Patients with type 2 diabetes mellitus (T2DM) will be included:
1. If HbA1c (glycated hemoglobin) is less than or equal to 10 %
2. If the subject is taking basal insulin only or oral hypoglycemic agents or a combination of those.
3. Patients on SGLT2-inhibitors and TZDs (Thiazolidinedione) will be included if they have been on a stable dose of these medications for at least 6 months
4. The following protocol will be adopted to adjust insulin sec
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
200
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SAMARA
Identifier
NCT06005012
Link
https://clinicaltrials.gov/study/NCT06005012
Phase
Phase II
Status
Unknown status
Sponsor
University of California, San Diego
More details
Conduct a community intervention study that will 1) validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and 2) test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients.
Purpose
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo
Countries
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-25
Anticipated Date of Last Follow-up
2023-09-01
Estimated Primary Completion Date
2025-03-01
Estimated Completion Date
2025-06-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
1. Adult, age ≥ 40 and \< 80 years
2. Participant must meet at least one of following sets of conditions:
1. BMI ≥ 27 kg/m² OR
2. BMI ≥ 25 kg/m² AND presence of i) pre-diabetes (HbA1C ≥ 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations.
The ADA definition of T2DM is applicable if one of the following criteria is met:
* Presence of diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) and casual plasma glucose ≥ 200 mg/dL (11.1 mmol/L)
* Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/L)
* Plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT)⁶⁸. If any of the above test results occur,
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
120
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STEP 6
Identifier
NCT03811574
Link
https://clinicaltrials.gov/study/NCT03811574
Phase
Phase III
Status
Completed
Sponsor
Novo Nordisk A/S
More details
This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for abou
Purpose
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo (semaglutide)
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-01-21
Anticipated Date of Last Follow-up
2022-02-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-11-20
Actual Completion Date
2020-11-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female, age more than or equal to 18 years at the time of signing informed consent
* BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
* History of at least one self-reported unsuccessful dietary effort to lose body weight
* For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Exclusion Criteria:
* A self-reported change
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
401
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4387
Identifier
NCT03598621
Link
https://clinicaltrials.gov/study/NCT03598621
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days
Purpose
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
Interventions
Intervention 1
Semaglutide, 0.5 mg/mL
Intervention 2
Semaglutide, 1.0 mg/mL
Intervention 3
Semaglutide, 1.34 mg/mL
Intervention 4
Semaglutide, 2.0 mg/mL
Intervention 5
DV3372, 0.5 mg/mL
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-07-23
Anticipated Date of Last Follow-up
2020-01-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-01-17
Actual Completion Date
2019-01-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prio
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
68
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE UK
Identifier
NCT03876015
Link
https://clinicaltrials.gov/study/NCT03876015
Phase
Marketed
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in United Kingdom, as Part of Local Clinical Practice (SURE UK)
Interventions
Intervention 1
Semaglutide
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-01
Anticipated Date of Last Follow-up
2021-01-15
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-08-12
Actual Completion Date
2020-08-12
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
215
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE GERMANY
Identifier
NCT04261933
Link
https://clinicaltrials.gov/study/NCT04261933
Phase
Marketed
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)
Interventions
Intervention 1
semaglutide
Countries
France
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-02-13
Anticipated Date of Last Follow-up
2023-03-24
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-05-25
Actual Completion Date
2021-05-25
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
789
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE FRANCE
Identifier
NCT04083820
Link
https://clinicaltrials.gov/study/NCT04083820
Phase
Marketed
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE)
Interventions
Intervention 1
semaglutide
Countries
Switzerland
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-09-16
Anticipated Date of Last Follow-up
2023-03-24
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-09-27
Actual Completion Date
2021-09-27
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
521
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE Switzerland
Identifier
NCT03631186
Link
https://clinicaltrials.gov/study/NCT03631186
Phase
Marketed
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these questionnaires during their normally scheduled visits with the study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Switzerland, as Part of Local Clinical Practice (SURE SWITZERLAND)
Interventions
Intervention 1
Semaglutide
Countries
Canada
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-09-12
Anticipated Date of Last Follow-up
2021-07-21
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-12-18
Actual Completion Date
2019-12-18
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
215
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE CANADA
Identifier
NCT03457012
Link
https://clinicaltrials.gov/study/NCT03457012
Phase
Marketed
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about the health and the diabetes treatment. Participants will complete these during the normally scheduled visits with the study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice
Interventions
Intervention 1
Semaglutide
Countries
Canada
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-03-29
Anticipated Date of Last Follow-up
2021-08-31
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-12-19
Actual Completion Date
2019-12-19
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
462
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9535-4367
Identifier
NCT03648281
Link
https://clinicaltrials.gov/study/NCT03648281
Phase
Not provided
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these questionnaires during their normally scheduled visits with the study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)
Interventions
Intervention 1
Semaglutide
Countries
Netherlands
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-24
Anticipated Date of Last Follow-up
2021-11-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-01-10
Actual Completion Date
2020-01-10
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
333
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE NL
Identifier
NCT03929679
Link
https://clinicaltrials.gov/study/NCT03929679
Phase
Not provided
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS)
Interventions
Intervention 1
semaglutide
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-28
Anticipated Date of Last Follow-up
2023-01-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-11-24
Actual Completion Date
2020-11-24
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
218
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STOP
Identifier
NCT03985384
Link
https://clinicaltrials.gov/study/NCT03985384
Phase
Marketed
Status
Completed
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
More details
The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis. Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium. This study will look specifically at the arteries involving the heart.
Purpose
Semaglutide Treatment On Coronary Progression
Interventions
Intervention 1
Semaglutide 2 MG/1.5 ML Subcutaneous Solution
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-04-30
Anticipated Date of Last Follow-up
2023-10-03
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-12-27
Actual Completion Date
2022-12-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Men or women with type 2 diabetes with a glycated hemoglobin level of 7.0% or more, drug naïve, or treated with oral agents and/or basal insulin. For patients on basal insulin at entry, the PI will consider dose reduction of basal insulin according to A1c and risk for hypoglycemia. Patients on SGLT-2 inhibitors may be screened but the agents must be discontinued at least 30 days prior to randomization.
* Age \> 40 years of age at the time of the initial Screening visit (V1) with a diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines and with at least one cardiovascular risk factor (hypertension, high cholesterol, family history of premature heart disease or past/current smoking) or prior ASCVD (prior stroke, TIA, claudication, coronary
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
140
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
24-05H
Identifier
NCT06468748
Link
https://clinicaltrials.gov/study/NCT06468748
Phase
Marketed
Status
Withdrawn
Sponsor
United States Army Research Institute of Environmental Medicine
More details
The obesity epidemic presents a growing concern in the United States, affecting more than 42% of adults. This epidemic extends its impact to chronic diseases and escalating healthcare expenses. Its reach has even influenced the military, with more than 20% of Soldiers being classified as obese, based on Body Mass Index ≥30 kg/m2. Current preventative and countermeasures have produced limited success, prompting consideration of pharmacotherapy. Within this context, glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, have emerged as a promising treatment for obesity. Semaglutide can induce significant weight loss, primarily through fat reduction. However, questions persist regarding its effects on lean mass, physical performance, bone structure, and how it influences t
Purpose
The Effects of Semaglutide on Body Composition and Performance in Military Personnel
Interventions
Intervention 1
Semaglutide
Countries
Denmark
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-08-01
Anticipated Date of Last Follow-up
2025-05-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2025-03-27
Actual Completion Date
2025-03-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Active-duty military personnel
* Age ≥ 18 years at the time of signing informed consent.
* Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, etc.)
* History of at least one self-reported effort to lose body weight.
* Ability to exercise ≥ 3x per week during the study.
Exclusion Criteria:
* Currently in Basic Combat Training, Advanced Individual Training, or One Station Unit Training, or equivalence in other military services.
* Current or history of Type 1 or Type 2 Diabetes, cardiovascular (e.g., heart disease, peripheral artery disease), musculoskeletal (e.g., myopathies), immune (e.g., lupus, asthma), gastrointestinal (e.g., irritable bowel syndrome, pancreatitis)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
TOTT
Identifier
NCT06619015
Link
https://clinicaltrials.gov/study/NCT06619015
Phase
Phase II/III
Status
Suspended
Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
More details
The two main aims of this clinical study is;
1. To investigate if the results from a series of physiological tests and questionnaires prior to treatment, can be used to predict the treatment response to obesity medication
2. To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite, food preference and eating habits.
The study is planed as a 26 week, double blinded, randomized, placebo controlled trial. The goal is to include N=40. They will all receive weekly semaglutide injections. After 24 weeks they will be randomized to receive either an amylin analog (pramlintide) or placebo as a continuous infusion for two weeks, in addition to weekly semaglutide.
The results from this study will contribute to identifying possible predictors of treatment re
Purpose
Tailoring Obesity Treatment Trial
Interventions
Intervention 1
Pramlintide Acetate 1 MG/ML
Intervention 2
Semaglutide Pen Injector
Intervention 3
Sodium Chloride 0.9% Inj
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-09-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-02-26
Estimated Primary Completion Date
2026-12-01
Estimated Completion Date
2026-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* BMI ≧ 30kg/m2
* HbA1c 39-47 mmol/mol (pre-diabetes)
* Male or female
* Aged \>18 years of age and \<70 years
* Negative pregnancy test, and willing to use contraceptives during the study period
Exclusion Criteria:
* Presence of diabetes with or without treatment
* Current or recent (\<6 months) treatment with GLP1 RA's
* Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production
* History of acute or chronic pancreatitis
* Chronic kidney disease
* Use of any antipsychotic drugs
* Use of any antiresorptive or bone-anabolic drugs or fractures within \< 6 months
* Use of systemic oral glucocorticoids within \< 6 months
* Newly (\< 3 months) initiated hormonal contraceptive or other hormone therap
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
40
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9838-8259
Identifier
NCT06716307
Link
https://clinicaltrials.gov/study/NCT06716307
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.
Purpose
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
Interventions
Intervention 1
CagriSema (cagrilintide B and semaglutide I)
Intervention 2
CagriSema A
Countries
Italy
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-12-02
Anticipated Date of Last Follow-up
2025-08-26
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2025-03-28
Actual Completion Date
2025-05-22
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
* Male or female.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
Overweight should be due to excess adipose tissue, as judged by the investigator.
\- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous dosing with an amylin analogue.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastroint
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE ITALY
Identifier
NCT04094415
Link
https://clinicaltrials.gov/study/NCT04094415
Phase
Not provided
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and your diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice
Interventions
Intervention 1
Semaglutide
Countries
Spain
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-10-28
Anticipated Date of Last Follow-up
2023-02-21
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-07-28
Actual Completion Date
2021-07-28
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
581
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SURE SPAIN
Identifier
NCT04067999
Link
https://clinicaltrials.gov/study/NCT04067999
Phase
Not provided
Status
Completed
Sponsor
Novo Nordisk A/S
More details
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.
Purpose
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice
Interventions
Intervention 1
Semaglutide
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-08-05
Anticipated Date of Last Follow-up
2021-09-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-07-19
Actual Completion Date
2021-07-19
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
230
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
GS-US-454-5533
Identifier
NCT03987074
Link
https://clinicaltrials.gov/study/NCT03987074
Phase
Phase II
Status
Completed
Sponsor
Gilead Sciences
More details
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
Purpose
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
Interventions
Intervention 1
Semaglutide
Intervention 2
Firsocostat
Intervention 3
Cilofexor
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-07-29
Anticipated Date of Last Follow-up
2021-06-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-07-13
Actual Completion Date
2020-07-13
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan
* Screening laboratory parameters, as determined by central laboratory:
* Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)
* Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation
* HbA1c ≤ 9.5%
* International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy
* Platelet count ≥ 100,000/μL
* Total b
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
109
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
FOCUS
Identifier
NCT03811561
Link
https://clinicaltrials.gov/study/NCT03811561
Phase
Phase III
Status
Not provided
Sponsor
Novo Nordisk A/S
More details
This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.
Purpose
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Interventions
Intervention 1
Semaglutide
Intervention 2
Placebo (semaglutide)
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-08
Anticipated Date of Last Follow-up
2025-08-10
Estimated Primary Completion Date
2026-12-25
Estimated Completion Date
2027-11-07
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus.
* HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
* Eye inclusion criteria (both eyes must meet all criteria):
* Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
* No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
* No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
* Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS v
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1500
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9388-7864
Identifier
NCT06797869
Link
https://clinicaltrials.gov/study/NCT06797869
Phase
Phase II
Status
Recruiting
Sponsor
Novo Nordisk A/S
More details
This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.
Purpose
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
Interventions
Intervention 1
CagriSema (Cagrilintide B and Semaglutide I)
Intervention 2
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-01-29
Anticipated Date of Last Follow-up
2025-08-26
Estimated Primary Completion Date
2026-08-21
Estimated Completion Date
2026-08-21
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m\^2) at screening.
* Diagnosis of type 2 diabetes (T2D) ≥180 days before screening.
\-- For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following anti-diabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator:
* Treatment with 1-3 marketed oral anti-diabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines.
* Treat
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
134
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9838-8484
Identifier
NCT07011667
Link
https://clinicaltrials.gov/study/NCT07011667
Phase
Phase III
Status
Not provided
Sponsor
Novo Nordisk A/S
More details
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriS
Purpose
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Interventions
Intervention 1
CagriSema (Cagrilintide B and Semaglutide I)
Intervention 2
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-06-03
Anticipated Date of Last Follow-up
2025-08-28
Estimated Primary Completion Date
2026-12-15
Estimated Completion Date
2028-11-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
key Inclusion Criteria:
* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening.
* Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.
key Exclusion Criteria:
* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
600
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
EmpaSema
Identifier
NCT04061200
Link
https://clinicaltrials.gov/study/NCT04061200
Phase
Marketed
Status
Unknown status
Sponsor
Steno Diabetes Center Copenhagen
More details
The objective of this study is to evaluate the effect of treatment with semaglutide 1.34 mg/ml in combination with empagliflozin 25 mg, compared to treatment with empagliflozin 25 mg in combination with placebo on albuminuria in participants with type 2 diabetes and albuminuria.
In a randomised, placebo-controlled, double-blinded, parallel trial we will include 80 patients with type 2 diabetes and albuminuria. Patients will start in a run-in phase of 26 weeks with empagliflozin 25 mg alone. After that, the patients will be randomised 1:1 to an active treatment period with semaglutide of 26 weeks or placebo for 26 weeks.
The primary endpoint is change from randomisation to week 52 in albuminuria, measured in three morning urine samples.
Purpose
Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria
Interventions
Intervention 1
Semaglutide, 1.34 mg/mL
Intervention 2
Placebo, 1,34 mg/mL
Intervention 3
Empagliflozin 25 MG
Countries
Denmark
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2019-11-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2019-08-16
Estimated Primary Completion Date
2021-07-01
Estimated Completion Date
2021-08-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Given written informed consent
2. Male or female patients ≥ 18 years with type 2 diabetes (WHO criteria).
3. UACR \> 100 mg/g within a year of informed consent documented in the medical files.
4. eGFR ≥ 30 ml/min/1.73 m2 (estimated by CKD-EPI formula) within 3 months of informed consent documented in the medical files. The eGFR measured at visit 0 has to meet the criteria as well.
5. Fertile female must use chemical, hormonal and mechanical contraceptives, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening
6. Treated with maximal tolerated dose of an angiotensin-converting-enzyme inhibitor or an an
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
80
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
SemaPsychiatry
Identifier
NCT04892199
Link
https://clinicaltrials.gov/study/NCT04892199
Phase
Marketed
Status
Not provided
Sponsor
Anders Fink-Jensen, MD, DMSci
More details
Background and objective:
Clozapine and olanzapine are some of the most effective antipsychotic drugs, but unfortunately, both drugs induce weight gain and conveys a high degree of metabolic disturbances. The antipsychotic-induced side-effects cause a major clinical problem among patients diagnosed with schizophrenia receiving antipsychotic treatment. Limited effects have been demonstrated for counteracting the side-effects by the switch of antipsychotic therapy, non-pharmacological/behavioural interventions or adjunct pharmacological treatments. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA,) is approved for the treatment of type 2 diabetes worldwide. The objective of the study is to investigate effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on
Purpose
Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Medication?
Interventions
Intervention 1
Semaglutide, 1.34 mg/mL
Intervention 2
Semaglutide-placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-09-01
Anticipated Date of Last Follow-up
2024-09-23
Estimated Primary Completion Date
2026-03-01
Estimated Completion Date
2026-08-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Informed oral and written consent
2. Diagnosed with schizophrenia according to the criteria of ICD-10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association)
3. Initiating current treatment with clozapine or olanzapine within 60 months (not PRN ordinations)
4. Age 18 years to 65 years (both included)
5. Body mass index (BMI) ≥25 kg/m2
6. Diagnosed with prediabetes or type 2 diabetes, after initiation of current treatment with clozapine- or olanzapine, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be con
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
104
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
STUDY00002775
Identifier
NCT03899402
Link
https://clinicaltrials.gov/study/NCT03899402
Phase
Phase II/III
Status
Not provided
Sponsor
State University of New York at Buffalo
More details
To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.
Purpose
Triple Therapy in T1DM
Interventions
Intervention 1
Insulin
Intervention 2
Semaglutide
Intervention 3
Dapagliflozin
Intervention 4
Placebo to Dapagliflozin
Countries
Germany
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-01
Anticipated Date of Last Follow-up
2025-03-31
Estimated Primary Completion Date
2026-01-31
Estimated Completion Date
2026-03-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Type 1 Diabetes for at least 1 year on staple use of continuous subcutaneous insulin infusion (CSII) or multiple daily (four or more) injections (MDI) of insulin for last 3 months.
2. C-peptide \<0.23 nM
3. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
4. Regularly measuring blood sugars four or more times daily.
5. HbA1c of \>7.5%.
6. Well versed in CHO counting\*
7. Age 18-70 years.
8. BMI ≥25 kg/m2.
Exclusion Criteria:
1. Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY
2. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.
3. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
78
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
NN9389-4681
Identifier
NCT05153564
Link
https://clinicaltrials.gov/study/NCT05153564
Phase
Phase I
Status
Completed
Sponsor
Novo Nordisk A/S
More details
Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet i
Purpose
A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-12-13
Anticipated Date of Last Follow-up
2023-11-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-08-13
Actual Completion Date
2022-09-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent
* Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
* Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfer
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
27
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
