survodutide

Associated long-acting platforms

Albumin-binding peptide conjugate, Peptide lipidation (C18 fatty diacid acylation enabling reversible albumin binding)

Administration route

Subcutaneous

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

Pre-filled syringe/pen-like injector to be confirmed.

Scale-up prospects

As a 29-residue lipidated peptide with one non-proteinogenic amino acid (Ac4c) and a long linker, survodutide requires specialised peptide API synthesis and purification capacity.

Tentative equipment list for manufacturing

Not provided

Manufacturing

Synthetic acylated peptide. Manufacturing process, formulation composition and container closure have not been publicly disclosed.

Specific analytical instrument required for characterization of formulation

Not provided

SYNCHRONIZE-1

Identifier

NCT06066515

Link

https://clinicaltrials.gov/study/NCT06066515

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Pa

Purpose

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-25

Anticipated Date of Last Follow-up
2026-03-11

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-12-02

Actual Completion Date
2026-02-20

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

726

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Not provided

Key resources

SYNCHRONIZE-2

Identifier

NCT06066528

Link

https://clinicaltrials.gov/study/NCT06066528

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of

Purpose

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-27

Anticipated Date of Last Follow-up
2026-08-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-12-12

Actual Completion Date
2026-04-01

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. 2. Body mass index (BMI) ≥27 kg/m\^2 at screening. 3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening. 4. HbA1c ≥6.5% (≥48 mmol/mol) and \<10% (\<86 mmol/mol) as measured by the central laboratory at screening. 5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. 6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply. Exclusion Criteria: 1. Body we

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

755

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE - CVOT

Identifier

NCT06077864

Link

https://clinicaltrials.gov/study/NCT06077864

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesi

Purpose

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-20

Anticipated Date of Last Follow-up
2026-09-29

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2026-06-01

Actual Completion Date
2026-06-30

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. 2. Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD. Further inclusion criteria apply. Exclusion criteria: 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening. 2. Type 1 diabetes. 3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotrop

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

5531

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE-JP

Identifier

NCT06176365

Link

https://clinicaltrials.gov/study/NCT06176365

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or * a BMI of 27 kg/m² or more and at least two health problems related to their weight. People who have either type 2 diabetes, high blood pressure, or increased blood lipids can take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like surv

Purpose

A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-01-16

Anticipated Date of Last Follow-up
2026-04-23

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-12-03

Actual Completion Date
2025-12-03

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent 2. Body Mass Index (BMI) * ≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR * BMI ≥27 kg/m² at screening with the presence of at least two obesity-related comorbidities (treated or untreated) according to the JASSO guideline For all trial patients, at least one co-morbidity should be the following (i)-(iii). i. Type 2 diabetes mellitus (T2DM) * Diagnosed with T2DM (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening * HbA1c ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol) as measured by t

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

274

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE-CN

Identifier

NCT06214741

Link

https://clinicaltrials.gov/study/NCT06214741

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity. 2 different doses of survodutide are tested in this study. Participants are put into 3 groups by chance. Each participant has an equal chance of being in each group. 2 groups get different doses of survodutide. 1 group gets placebo. Participants get survodutide or placebo as injections under the skin once a week for about 19 months. Placebo injections look like survodutide injections but do not contain any medicine.

Purpose

A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-02-06

Anticipated Date of Last Follow-up
2026-04-22

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-07-29

Actual Completion Date
2026-01-28

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent. 2. Body mass index (BMI) ≥28 kg/m\^2 at screening, OR BMI ≥24 kg/m\^2 at screening with the presence of at least one of the following weight-related complications: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 mmHg and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥1

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

307

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE-MASLD

Identifier

NCT06309992

Link

https://clinicaltrials.gov/study/NCT06309992

Phase

Phase III

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine

Purpose

A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-04-02

Anticipated Date of Last Follow-up
2026-04-24

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-10-09

Actual Completion Date
2025-12-02

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Key inclusion criteria: * Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years * BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, Systolic Blood Pressure (SBP) values of ≥140 mmHg and/or Diastolic Blood Pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 antihypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or lowdensity lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L) or triglycerides

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

218

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

1404-0115

Identifier

NCT07754461

Link

https://clinicaltrials.gov/study/NCT07754461

Phase

Phase III

Status

Recruiting

Sponsor

Boehringer Ingelheim

More details

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two g

Purpose

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-08-24

Anticipated Date of Last Follow-up
2026-09-29

Estimated Primary Completion Date
2028-01-17

Estimated Completion Date
2028-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C: 1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol/mol) and \<9.5% (\<80 mmol/mol) as measured by the central laboratory at screening (Visit 1); 2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for

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

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE-START

Identifier

NCT07855900

Link

https://clinicaltrials.gov/study/NCT07855900

Phase

Phase III

Status

Not yet recruiting

Sponsor

Boehringer Ingelheim

More details

This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight. This study has 2 groups. The groups differ based on their starting dose and whether they have used similar weight-loss medicines before. Participants are put into one of the 2 groups, but everyone in the study receives the study medicine, survodutide. Participants take the medicine as an injection under the skin on

Purpose

SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-11-07

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2026-09-29

Estimated Primary Completion Date
2028-06-25

Estimated Completion Date
2028-06-25

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

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 at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. History of at least one self-reported unsuccessful dietary effort to lose body weight 3. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently 4. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply. Exclusion criteria: 1. Body weight change (self-reported) \>2.5% during run-in period before screening 2.

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

350

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SYNCHRONIZE-HERA

Identifier

NCT07850050

Link

https://clinicaltrials.gov/study/NCT07850050

Phase

Phase III

Status

Not yet recruiting

Sponsor

Boehringer Ingelheim

More details

This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps women with overweight or obesity lose weight. Participants are put into 2 groups randomly, which means by chance. Participants have a 1 in 2 chance of receiving survodutide. One group gets survodutide as an injection under t

Purpose

SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-10-31

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2026-09-25

Estimated Primary Completion Date
2028-07-26

Estimated Completion Date
2028-07-26

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria: 1. Signed and dated written informed consent in accordance with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 2. Female (sex assigned at birth) with age \>18 years at the time of screening 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. Women of Childbearing Potential (WOCBP) must be ready and able to use at least an acceptable effective contraceptive method of birth control Further inclusion criteria apply. Exclusion criteria: 1. Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) 2. Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1) 3. Treatment with any medi

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

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ELEVATE-LIVER

Identifier

NCT07850063

Link

https://clinicaltrials.gov/study/NCT07850063

Phase

Phase III

Status

Not yet recruiting

Sponsor

Boehringer Ingelheim

More details

This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the pa

Purpose

ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-10-23

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2026-09-25

Estimated Primary Completion Date
2029-04-29

Estimated Completion Date
2029-04-29

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Key inclusion criteria: 1. Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial 3. Body mass index (BMI) ≥27 kg/m² 4. Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply. Key exclusion criteria: 1. Medications for obesity within 3 months before screening 2. Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products 3. Established diagnosis of heart failure or a known history of heart fa

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

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LIVERAGE

Identifier

NCT06632444

Link

https://clinicaltrials.gov/study/NCT06632444

Phase

Phase III

Status

Recruiting

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver functio

Purpose

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-10-14

Anticipated Date of Last Follow-up
2026-09-30

Estimated Primary Completion Date
2031-12-27

Estimated Completion Date
2031-12-27

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria: 1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent 2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4 3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used 4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply Exclusion criteria: 1. Any of the following liver laboratory test abnormalities at screening: * Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN) * Plat

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

1800

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LIVERAGE-Cirrhosis

Identifier

NCT06632457

Link

https://clinicaltrials.gov/study/NCT06632457

Phase

Phase III

Status

Recruiting

Sponsor

Boehringer Ingelheim

More details

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. P

Purpose

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-11-12

Anticipated Date of Last Follow-up
2026-09-30

Estimated Primary Completion Date
2029-06-05

Estimated Completion Date
2029-06-05

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria: 1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants) 3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. 4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver bi

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

1590

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ARTIST-CKD

Identifier

NCT07206290

Link

https://clinicaltrials.gov/study/NCT07206290

Phase

Phase II

Status

Not yet recruiting

Sponsor

University Medical Center Groningen

More details

The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.

Purpose

Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Interventions

Intervention 1

Intervention 2

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-03-02

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2025-09-25

Estimated Primary Completion Date
2027-11-30

Estimated Completion Date
2027-11-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age ≥ 18 years * eGFR ≥20 and \<90 mL/min/1.73m2 * Urinary albumin to creatinine ratio \>30 mg/g and \<3500 mg/g * BMI \>21 kg/m2 * Stable kidney function (no more than 30% change in eGFR in the 3 months prior to enrolment) * On a stable maximum tolerated dose of an ACEi/ARB for at least 4 weeks prior to enrolment * If using an SGLT2 inhibitor, receiving a stable dose for at least 8 weeks prior to enrolment * Willing to sign an informed consent Exclusion Criteria: * Diagnosis of type 1 diabetes * Cardiovascular event within 3 months prior to enrolment * Treatment with GLP-1RA for \<12 weeks prior to screening * Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesoph

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

120

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Phase II obesity

Identifier

NCT04667377

Link

https://clinicaltrials.gov/study/NCT04667377

Phase

Phase II

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between t

Purpose

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-03-08

Anticipated Date of Last Follow-up
2023-10-06

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-09-15

Actual Completion Date
2022-10-07

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Adult ≥ 18 years and \< 75 years of age at screening * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. * Obesity or Overweight defined as BMI ≥27 kg/m2 at screening * A minimum absolute body weight of 70 kg for females and 80 kg for males at screening * Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. * Patients must have undergone

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

387

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Phase II type 2 diabetes

Identifier

NCT04153929

Link

https://clinicaltrials.gov/study/NCT04153929

Phase

Phase II

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7

Purpose

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-04-30

Anticipated Date of Last Follow-up
2022-11-02

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2021-10-08

Actual Completion Date
2021-11-04

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria: * Signed and dated written informed consent in accordance with International conference on harmonization - Good clinical practice (ICH GCP) and local legislation. * Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent. * Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent. * Glycosylated hemoglobin A1c (HbA1c) 7.0%-10.0% (both inclusive) at screening. * Treatment with a stable dose of metformin ≥ 1000mg/day for at least 3 months prior to screening. * Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at screening. * Women of childbearing potential must be ready and able to use highly effective methods of birth control. Exclusion criteria: * Patients with type 1 diabetes

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

413

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Phase II MASH

Identifier

NCT04771273

Link

https://clinicaltrials.gov/study/NCT04771273

Phase

Phase II

Status

Completed

Sponsor

Boehringer Ingelheim

More details

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times an

Purpose

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-04-27

Anticipated Date of Last Follow-up
2024-11-07

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-11-09

Actual Completion Date
2023-12-21

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Male or female patients ≥ 18 years (or who are of legal age in countries where that is greater than 18 years) and ≤ 80 years of age at time of consent. 2. Diagnosis of non-alcoholic steatohepatitis (NASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F1-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomization and stable body weight defined as less than 5% self-reported change in body weight between the historical biopsy and randomization, if a historical biopsy is used. 3. Liver fat fraction ≥ 8% measured by Magnetic Resonance Imaging (MRI)-Proton Density Fat Fraction (PDFF) and li

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

295

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

Survodutide Once Weekly for the Treatment of Adults with Obesity

Carel W. le Roux — New England Journal of Medicines — 2026-06-07

Background

Although medications with glucagon-like peptide-1 (GLP-1) receptor agonist activity have transformed the management of obesity and shown substantial cardiometabolic benefits, unmet needs remain. Survodutide, an investigational glucagon receptor–GLP-1 receptor dual agonist, led to substantial weight reduction in a phase 2 trial involving adults with obesity without diabetes.

Methods

In this phase 3, double-blind trial, we randomly assigned adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher, or 27 or higher with at least one obesity-related complication (excluding diabetes), in a 1:1:1 ratio to receive once-weekly survodutide administered subcutaneously at a dose adjusted up to 3.6 mg or 6.0 mg or placebo, in addition to counseling for lifestyle modification. The two primary end points were the percent change in body weight and a reduction in body weight of at least 5% from baseline to week 76. The primary efficacy analysis was conducted according to the treatment-regimen estimand, which incorporates the effects of any early discontinuation of survodutide or placebo, the use of protocol-prohibited obesity medications, and a prolonged dose-escalation period.

Results

Among 725 participants (241 in the 3.6-mg survodutide group, 242 in the 6.0-mg survodutide group, and 242 in the placebo group), the mean age was 47.1 years; 294 participants (40.6%) were men. At baseline, the mean BMI was 37.9, and the mean body weight was 108.8 kg. At week 76, the mean change in body weight from baseline according to the treatment-regimen estimand was –12.2% (95% confidence interval [CI], −13.6 to −10.8) in the 3.6-mg group, –13.0% (95% CI, −14.4 to −11.6) in the 6.0-mg group, and –5.4% (95% CI, −6.9 to −4.0) in the placebo group; 72.6%, 71.9% and 46.3% of the participants, respectively, had weight reduction of at least 5% (P<0.001 for all comparisons with placebo). The most common adverse events were gastrointestinal symptoms (typically mild to moderate), which occurred in 80.9% of the participants in the 3.6-mg group, in 89.7% of those in the 6.0-mg group, and in 47.9% of those in the placebo group. No deaths were reported.

Conclusions

Survodutide led to significantly greater reductions in body weight than placebo in adults with obesity without diabetes. (Funded by Boehringer Ingelheim; SYNCHRONIZE-1 ClinicalTrials.gov number, NCT06066515.)

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