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Frederick, M. O., Boyse, R. A., Braden, T. M., Calvin, J. R., Campbell, B. M., Changi, S. M., ... & Xia, H. (2021). Kilogram-scale GMP manufacture of tirzepatide using a hybrid SPPS/LPPS approach with

tirzepatide (TIRZE)

Developer(s)

Eli Lilly and Company

Originator
https://www.lilly.com/

United States of America

Colonel Eli Lilly created Eli Lilly and Company, also known as Lilly, an American international pharmaceutical firm with headquarters in Indianapolis, Indiana, and offices in 18 countries, in 1876. The company researches, develops, produces, and markets medicinal products, with a focus on therapeutic areas such as diabetes, oncology, immunology, and neuroscience.

Drug structure

Structure of tirzepatide (39 amino acids) using single-letter codes to denote amino acids.

Structure of tirzepatide (39 amino acids) using single-letter codes to denote amino acids.

Frederick, M. O., Boyse, R. A., Braden, T. M., Calvin, J. R., Campbell, B. M., Changi, S. M., ... & Xia, H. (2021). Kilogram-scale GMP manufacture of tirzepatide using a hybrid SPPS/LPPS approach with

Drug information

Associated long-acting platforms

Solution

Administration route

Subcutaneous

Therapeutic area(s)

Diabetes : "Also investigated in Type 1 diabetes"
Obesity / Weight Management
Cardiovascular : "Heart Failure with Preserved Ejection Fraction (HFpEF) and cardiovascular mortality reduction (investigational)"
obstructive sleep apnea
Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH) : "investigational"

Use case(s)

Treatment
Prevention

Use of drug

Ease of administration

Administered by a community health worker
Administered by a nurse
Administered by a specialty health worker
Self-administered

Frequency of administration

Weekly

User acceptance

Not provided

Dosage

Available dose and strength

2.5 mg/0.5 ml; 5 mg/0.5 ml; 7.5 mg/0.5 ml; 10 mg/0.5 ml; 12.5 mg/0.5 ml; 15 mg/0.5 ml

Maximum dose

15 mg SC Q1W (once weekly)

Recommended dosing regimen

Initial Dose: 2.5 mg SC Q1W Maintenance dose: After 4 weeks, increase to 5 mg SC Q1W, then every 4 weeks, increase the dose by 2.5 mg increments.

Additional comments

Inject the tirzepatide prefilled injection subcutaneously in the abdomen, thigh, or upper arm

Dosage link(s)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

Drug information

Drug's link(s)

https://go.drugbank.com/drugs/DB15171

Generic name

Tirzepatide

Brand name

Mounjaro; Zepbound

Compound type

Biotherapeutic

Drug class/category

Not provided

Summary

Tirzepatide, a therapeutic protein with a molecular weight of 4810.52 Da, functions as a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist. It is used to treat type 2 diabetes (T2DM). The half-life is around 5 days, with peak concentrations ranging from 8 to 72 hours. Tirzepatide mimics native GIP at the GIP receptor, but at the GLP-1 receptor, it favors cAMP generation over β-arrestin recruitment, resulting in a lower ability to stimulate GLP-1 receptor internalization compared to GLP-1. Additionally, patients administered tirzepatide experience substantial weight reduction.

Approval status

Tirzepatide, in various strengths has been approved in more than 40 countries, for use in one or more indications.

Regulatory authorities

Mounjaro and Zepbound are approved by several regulatory authorities globally

Delivery device(s)

No delivery device

Scale-up and manufacturing prospects

Scale-up prospects

Investment in Tirzepatide API production has risen to 9 million USD in 2024 by the innovator.

Tentative equipment list for manufacturing

Plug-Flow Reactors (PFRs), PTFE tubing and inline mixers, temperature-controlled baths, surge vessels, nanofiltration systems with ceramic membranes, high-pressure pumps, glass-lined or stainless-steel reactors, cooling systems, MTBE precipitation tanks, filtration units, and vacuum dryers.

Manufacturing

Tirzepatide is manufactured in an ISO 8/7 room using a hybrid SPPS/LPPS strategy. Four peptide fragments are first synthesized via SPPS, then coupled in solution using continuous flow reactors with real-time HPLC monitoring. Step 1: Join fragments 2 and 3 in DMSO/ACN with PyOxim and iPr₂NEt, followed by Fmoc removal and nanofiltration. Step 2: Couple the product with fragment 4 under similar conditions, then solvent-swap to DMF. Step 3: Join fragment 5 using HATU at 0°C, followed by precipitation. Step 4: Remove 19 protecting groups using TFA/TIPS/DTT, resulting in crude tirzepatide.

Specific analytical instrument required for characterization of formulation

1. HPLC (High-Performance Liquid Chromatography)/ PATROL HPLC 2. Mass Spectrometry (MS)

Clinical trials

A Study of Tirzepatide (LY3298176) in Healthy Participants

Identifier

NCT03375463

Link

https://clinicaltrials.gov/study/NCT03375463

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Tirzepatide

Intervention 3

Placebo

Intervention 4

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-12-19

Anticipated Date of Last Follow-up
2024-02-02

Estimated Primary Completion Date
2018-12-27 00:00:00

Estimated Completion Date
2018-12-27 00:00:00

Actual Primary Completion Date
2018-12-27

Actual Completion Date
2018-12-27

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

Interventional (clinical trial)

Enrollment

52

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

Identifier

NCT04050670

Link

https://clinicaltrials.gov/study/NCT04050670

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-09-13

Anticipated Date of Last Follow-up
2023-04-10

Estimated Primary Completion Date
2020-04-03 00:00:00

Estimated Completion Date
2020-04-03 00:00:00

Actual Primary Completion Date
2020-04-03

Actual Completion Date
2020-04-03

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

Interventional (clinical trial)

Enrollment

54

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Identifier

NCT05978713

Link

https://clinicaltrials.gov/study/NCT05978713

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-07-31

Anticipated Date of Last Follow-up
2025-04-09

Estimated Primary Completion Date
2024-03-12 00:00:00

Estimated Completion Date
2024-03-12 00:00:00

Actual Primary Completion Date
2024-03-12

Actual Completion Date
2024-03-12

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

Interventional (clinical trial)

Enrollment

11

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan

Identifier

NCT06635057

Link

https://clinicaltrials.gov/study/NCT06635057

Phase

Marketed

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-10-11

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2026-04-01

Estimated Completion Date
2026-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-04-01 00:00:00

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

Interventional (clinical trial)

Enrollment

130

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Identifier

NCT06864026

Link

https://clinicaltrials.gov/study/NCT06864026

Phase

Marketed

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-03-06

Anticipated Date of Last Follow-up
2025-11-21

Estimated Primary Completion Date
2027-11-01

Estimated Completion Date
2027-11-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-02-01 00:00:00

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

Interventional (clinical trial)

Enrollment

200

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

Identifier

NCT06857942

Link

https://clinicaltrials.gov/study/NCT06857942

Phase

Marketed

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-03-19

Anticipated Date of Last Follow-up
2025-11-21

Estimated Primary Completion Date
2028-05-01

Estimated Completion Date
2028-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-10-01 00:00:00

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

Interventional (clinical trial)

Enrollment

200

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function

Identifier

NCT03482024

Link

https://clinicaltrials.gov/study/NCT03482024

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-03-30

Anticipated Date of Last Follow-up
2022-06-09

Estimated Primary Completion Date
2019-08-19 00:00:00

Estimated Completion Date
2019-08-19 00:00:00

Actual Primary Completion Date
2019-08-19

Actual Completion Date
2019-08-19

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

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

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Participants With Impaired Liver Function

Identifier

NCT03940742

Link

https://clinicaltrials.gov/study/NCT03940742

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-07-22

Anticipated Date of Last Follow-up
2022-06-09

Estimated Primary Completion Date
2020-09-22 00:00:00

Estimated Completion Date
2020-09-22 00:00:00

Actual Primary Completion Date
2020-09-22

Actual Completion Date
2020-09-22

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

Interventional (clinical trial)

Enrollment

32

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity

Identifier

NCT05912621

Link

https://clinicaltrials.gov/study/NCT05912621

Phase

Phase II

Status

Recruiting

Sponsor

Stanford University

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-09

Anticipated Date of Last Follow-up
2024-12-02

Estimated Primary Completion Date
2028-06-01

Estimated Completion Date
2029-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2029-12-01 00:00:00

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

Interventional (clinical trial)

Enrollment

66

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants

Identifier

NCT06890611

Link

https://clinicaltrials.gov/study/NCT06890611

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Bimagrumab

Intervention 2

Tirzepatide

Intervention 3

Bimagrumab + Tirzepatide Coformulation

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-03-25

Anticipated Date of Last Follow-up
2025-10-08

Estimated Primary Completion Date
2025-09-01 00:00:00

Estimated Completion Date
2025-09-01 00:00:00

Actual Primary Completion Date
2025-09-26

Actual Completion Date
2025-09-26

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

Interventional (clinical trial)

Enrollment

125

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Identifier

NCT05706506

Link

https://clinicaltrials.gov/study/NCT05706506

Phase

Marketed

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-03-08

Anticipated Date of Last Follow-up
2024-12-10

Estimated Primary Completion Date
2023-10-31 00:00:00

Estimated Completion Date
2023-10-31 00:00:00

Actual Primary Completion Date
2023-10-31

Actual Completion Date
2023-10-31

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

Interventional (clinical trial)

Enrollment

152

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Identifier

NCT04407234

Link

https://clinicaltrials.gov/study/NCT04407234

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Acetaminophen

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-15

Anticipated Date of Last Follow-up
2023-04-11

Estimated Primary Completion Date
2021-01-07 00:00:00

Estimated Completion Date
2021-01-07 00:00:00

Actual Primary Completion Date
2021-01-07

Actual Completion Date
2021-01-07

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

Interventional (clinical trial)

Enrollment

36

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)

Identifier

NCT05963022

Link

https://clinicaltrials.gov/study/NCT05963022

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-08-21

Anticipated Date of Last Follow-up
2025-10-07

Estimated Primary Completion Date
2024-10-09 00:00:00

Estimated Completion Date
2024-10-09 00:00:00

Actual Primary Completion Date
2024-10-09

Actual Completion Date
2024-10-09

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

Interventional (clinical trial)

Enrollment

206

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Identifier

NCT06588296

Link

https://clinicaltrials.gov/study/NCT06588296

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Ixekizumab

Intervention 2

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-09-24

Anticipated Date of Last Follow-up
2025-11-21

Estimated Primary Completion Date
2025-11-01

Estimated Completion Date
2026-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-08-01 00:00:00

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

Interventional (clinical trial)

Enrollment

250

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Identifier

NCT06439277

Link

https://clinicaltrials.gov/study/NCT06439277

Phase

Phase III

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-06-03

Anticipated Date of Last Follow-up
2025-12-08

Estimated Primary Completion Date
2027-10-01

Estimated Completion Date
2030-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2030-12-01

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

Interventional (clinical trial)

Enrollment

300

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Identifier

NCT06588283

Link

https://clinicaltrials.gov/study/NCT06588283

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Ixekizumab

Intervention 2

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-09-30

Anticipated Date of Last Follow-up
2025-10-15

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2026-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

250

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

Identifier

NCT06901349

Link

https://clinicaltrials.gov/study/NCT06901349

Phase

Phase II

Status

Withdrawn

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Bimagrumab

Intervention 2

Tirzepatide

Intervention 3

Bimagrumab Placebo

Intervention 4

Tirzepatide Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-05-23

Anticipated Date of Last Follow-up
2025-09-19

Estimated Primary Completion Date
2026-10-01 00:00:00

Estimated Completion Date
2027-01-01 00:00:00

Actual Primary Completion Date
2025-06-10

Actual Completion Date
2025-06-10

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

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

Identifier

NCT05691712

Link

https://clinicaltrials.gov/study/NCT05691712

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-02-05

Anticipated Date of Last Follow-up
2025-07-21

Estimated Primary Completion Date
2024-07-01 00:00:00

Estimated Completion Date
2024-07-01 00:00:00

Actual Primary Completion Date
2024-07-01

Actual Completion Date
2024-07-01

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

Interventional (clinical trial)

Enrollment

257

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

Identifier

NCT06643728

Link

https://clinicaltrials.gov/study/NCT06643728

Phase

Phase II

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Bimagrumab

Intervention 2

Tirzepatide

Intervention 3

Bimagrumab Placebo

Intervention 4

Tirzepatide Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-10-21

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

Estimated Primary Completion Date
2026-04-01

Estimated Completion Date
2027-01-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-01-01 00:00:00

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

Interventional (clinical trial)

Enrollment

240

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Identifier

NCT06047548

Link

https://clinicaltrials.gov/study/NCT06047548

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-09-20

Anticipated Date of Last Follow-up
2025-04-17

Estimated Primary Completion Date
2026-05-01

Estimated Completion Date
2026-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

400

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

Identifier

NCT04844918

Link

https://clinicaltrials.gov/study/NCT04844918

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-05-10

Anticipated Date of Last Follow-up
2024-06-20

Estimated Primary Completion Date
2023-06-24 00:00:00

Estimated Completion Date
2023-06-24 00:00:00

Actual Primary Completion Date
2023-06-24

Actual Completion Date
2023-06-24

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

Interventional (clinical trial)

Enrollment

267

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

Identifier

NCT05696847

Link

https://clinicaltrials.gov/study/NCT05696847

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-02-07

Anticipated Date of Last Follow-up
2025-08-22

Estimated Primary Completion Date
2025-01-16

Estimated Completion Date
2025-01-16

Actual Primary Completion Date
2025-01-16

Actual Completion Date
2025-01-16

Studied populations

Age Cohort

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

Interventional (clinical trial)

Enrollment

28

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes

Identifier

NCT03861052

Link

https://clinicaltrials.gov/study/NCT03861052

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Dulaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-05-07

Anticipated Date of Last Follow-up
2022-04-13

Estimated Primary Completion Date
2021-03-10 00:00:00

Estimated Completion Date
2021-03-31 00:00:00

Actual Primary Completion Date
2021-03-10

Actual Completion Date
2021-03-31

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

Interventional (clinical trial)

Enrollment

636

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

Identifier

NCT04657003

Link

https://clinicaltrials.gov/study/NCT04657003

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-03-29

Anticipated Date of Last Follow-up
2024-03-08

Estimated Primary Completion Date
2023-03-16 00:00:00

Estimated Completion Date
2023-04-10 00:00:00

Actual Primary Completion Date
2023-03-16

Actual Completion Date
2023-04-10

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

Interventional (clinical trial)

Enrollment

938

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

Identifier

NCT06373146

Link

https://clinicaltrials.gov/study/NCT06373146

Phase

Phase II

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Mibavademab

Intervention 3

Tirzepatide-Placebo

Intervention 4

Mibavademab-Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-04-24

Anticipated Date of Last Follow-up
2025-10-15

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2026-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-04-01 00:00:00

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

Interventional (clinical trial)

Enrollment

360

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

Identifier

NCT05024032

Link

https://clinicaltrials.gov/study/NCT05024032

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-09-01

Anticipated Date of Last Follow-up
2023-12-26

Estimated Primary Completion Date
2022-12-27 00:00:00

Estimated Completion Date
2022-12-27 00:00:00

Actual Primary Completion Date
2022-12-27

Actual Completion Date
2022-12-27

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

Interventional (clinical trial)

Enrollment

210

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Identifier

NCT04660643

Link

https://clinicaltrials.gov/study/NCT04660643

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-03-29

Anticipated Date of Last Follow-up
2024-05-21

Estimated Primary Completion Date
2023-04-25 00:00:00

Estimated Completion Date
2023-05-18 00:00:00

Actual Primary Completion Date
2023-04-25

Actual Completion Date
2023-05-18

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

Interventional (clinical trial)

Enrollment

783

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

Identifier

NCT03954834

Link

https://clinicaltrials.gov/study/NCT03954834

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-06-03

Anticipated Date of Last Follow-up
2021-10-18

Estimated Primary Completion Date
2020-10-05 00:00:00

Estimated Completion Date
2020-10-28 00:00:00

Actual Primary Completion Date
2020-10-05

Actual Completion Date
2020-10-28

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

Interventional (clinical trial)

Enrollment

478

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

Identifier

NCT04847557

Link

https://clinicaltrials.gov/study/NCT04847557

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-04-20

Anticipated Date of Last Follow-up
2025-08-15

Estimated Primary Completion Date
2024-07-02 00:00:00

Estimated Completion Date
2024-07-02 00:00:00

Actual Primary Completion Date
2024-07-02

Actual Completion Date
2024-07-02

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

Interventional (clinical trial)

Enrollment

731

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Identifier

NCT06297616

Link

https://clinicaltrials.gov/study/NCT06297616

Phase

Phase I

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

LY3841136

Intervention 2

LY3841136-Placebo

Intervention 3

Tirzepatide

Intervention 4

Tirzepatide-Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-04-15

Anticipated Date of Last Follow-up
2025-04-17

Estimated Primary Completion Date
2025-11-01

Estimated Completion Date
2025-11-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2025-11-01 00:00:00

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

Interventional (clinical trial)

Enrollment

128

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

Identifier

NCT04657016

Link

https://clinicaltrials.gov/study/NCT04657016

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-03-29

Anticipated Date of Last Follow-up
2024-05-08

Estimated Primary Completion Date
2023-04-20 00:00:00

Estimated Completion Date
2023-05-12 00:00:00

Actual Primary Completion Date
2023-04-20

Actual Completion Date
2023-05-12

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

Interventional (clinical trial)

Enrollment

579

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

Identifier

NCT04081337

Link

https://clinicaltrials.gov/study/NCT04081337

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-07-09

Anticipated Date of Last Follow-up
2023-05-26

Estimated Primary Completion Date
2022-05-26 00:00:00

Estimated Completion Date
2022-05-26 00:00:00

Actual Primary Completion Date
2022-05-26

Actual Completion Date
2022-05-26

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

Interventional (clinical trial)

Enrollment

55

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Identifier

NCT04184622

Link

https://clinicaltrials.gov/study/NCT04184622

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-12-04

Anticipated Date of Last Follow-up
2025-07-03

Estimated Primary Completion Date
2022-04-01 00:00:00

Estimated Completion Date
2024-07-06 00:00:00

Actual Primary Completion Date
2022-04-01

Actual Completion Date
2024-07-06

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

Interventional (clinical trial)

Enrollment

2539

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

Identifier

NCT04004988

Link

https://clinicaltrials.gov/study/NCT04004988

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Prefilled syringe (PFS)

Intervention 3

Auto-injector (AI)

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-08-19

Anticipated Date of Last Follow-up
2023-04-17

Estimated Primary Completion Date
2019-12-16 00:00:00

Estimated Completion Date
2019-12-16 00:00:00

Actual Primary Completion Date
2019-12-16

Actual Completion Date
2019-12-16

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

Interventional (clinical trial)

Enrollment

47

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

Identifier

NCT05708859

Link

https://clinicaltrials.gov/study/NCT05708859

Phase

Marketed

Status

Recruiting

Sponsor

Matthew J. Budoff

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-01-02

Anticipated Date of Last Follow-up
2024-10-10

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2026-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

120

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

Identifier

NCT04235959

Link

https://clinicaltrials.gov/study/NCT04235959

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-10-21

Anticipated Date of Last Follow-up
2022-08-11

Estimated Primary Completion Date
2021-08-17 00:00:00

Estimated Completion Date
2021-08-17 00:00:00

Actual Primary Completion Date
2021-08-17

Actual Completion Date
2021-08-17

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

Interventional (clinical trial)

Enrollment

24

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)

Identifier

NCT06191848

Link

https://clinicaltrials.gov/study/NCT06191848

Phase

Marketed

Status

Recruiting

Sponsor

University of Melbourne

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-11-19

Anticipated Date of Last Follow-up
2025-04-27

Estimated Primary Completion Date
2027-05-01

Estimated Completion Date
2037-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2037-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

352

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Identifier

NCT05822830

Link

https://clinicaltrials.gov/study/NCT05822830

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Semaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-04-21

Anticipated Date of Last Follow-up
2025-11-14

Estimated Primary Completion Date
2024-11-13 00:00:00

Estimated Completion Date
2024-11-13 00:00:00

Actual Primary Completion Date
2024-11-13

Actual Completion Date
2024-11-13

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

Interventional (clinical trial)

Enrollment

751

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Identifier

NCT03311724

Link

https://clinicaltrials.gov/study/NCT03311724

Phase

Phase II

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-10-19

Anticipated Date of Last Follow-up
2021-04-28

Estimated Primary Completion Date
2018-04-24 00:00:00

Estimated Completion Date
2018-04-24 00:00:00

Actual Primary Completion Date
2018-04-24

Actual Completion Date
2018-04-24

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

Interventional (clinical trial)

Enrollment

111

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Study of Tirzepatide in Healthy Participants

Identifier

NCT04311424

Link

https://clinicaltrials.gov/study/NCT04311424

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

14C Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-07-28

Anticipated Date of Last Follow-up
2022-06-09

Estimated Primary Completion Date
2020-10-02 00:00:00

Estimated Completion Date
2020-10-02 00:00:00

Actual Primary Completion Date
2020-10-02

Actual Completion Date
2020-10-02

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

Interventional (clinical trial)

Enrollment

6

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Identifier

NCT03322631

Link

https://clinicaltrials.gov/study/NCT03322631

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-11-15

Anticipated Date of Last Follow-up
2022-06-09

Estimated Primary Completion Date
2018-05-29 00:00:00

Estimated Completion Date
2018-11-28 00:00:00

Actual Primary Completion Date
2018-05-29

Actual Completion Date
2018-11-28

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

Interventional (clinical trial)

Enrollment

48

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Identifier

NCT06037252

Link

https://clinicaltrials.gov/study/NCT06037252

Phase

Phase II

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-09-21

Anticipated Date of Last Follow-up
2025-05-26

Estimated Primary Completion Date
2026-01-01

Estimated Completion Date
2026-10-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-10-01 00:00:00

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

Interventional (clinical trial)

Enrollment

350

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Identifier

NCT06662383

Link

https://clinicaltrials.gov/study/NCT06662383

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Retatrutide

Intervention 2

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-11-01

Anticipated Date of Last Follow-up
2025-04-25

Estimated Primary Completion Date
2026-12-01

Estimated Completion Date
2026-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-12-01 00:00:00

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

Interventional (clinical trial)

Enrollment

800

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Identifier

NCT04255433

Link

https://clinicaltrials.gov/study/NCT04255433

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Dulaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-05-29

Anticipated Date of Last Follow-up
2025-08-22

Estimated Primary Completion Date
2025-06-12 00:00:00

Estimated Completion Date
2025-06-12 00:00:00

Actual Primary Completion Date
2025-06-12

Actual Completion Date
2025-06-12

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

Interventional (clinical trial)

Enrollment

13299

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Identifier

NCT06914895

Link

https://clinicaltrials.gov/study/NCT06914895

Phase

Phase III

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-04-25

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2027-05-01

Estimated Completion Date
2027-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

905

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

Identifier

NCT04166773

Link

https://clinicaltrials.gov/study/NCT04166773

Phase

Phase II

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-11-19

Anticipated Date of Last Follow-up
2025-01-22

Estimated Primary Completion Date
2023-12-11 00:00:00

Estimated Completion Date
2024-01-10 00:00:00

Actual Primary Completion Date
2023-12-11

Actual Completion Date
2024-01-10

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

Interventional (clinical trial)

Enrollment

190

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

Identifier

NCT06962280

Link

https://clinicaltrials.gov/study/NCT06962280

Phase

Phase III

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-05-12

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2027-04-01

Estimated Completion Date
2027-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-12-01 00:00:00

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

Interventional (clinical trial)

Enrollment

465

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

Identifier

NCT05556512

Link

https://clinicaltrials.gov/study/NCT05556512

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-10-11

Anticipated Date of Last Follow-up
2025-11-21

Estimated Primary Completion Date
2027-10-01

Estimated Completion Date
2027-10-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-10-01 00:00:00

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

Interventional (clinical trial)

Enrollment

15374

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS)

Identifier

NCT06075667

Link

https://clinicaltrials.gov/study/NCT06075667

Phase

Phase III

Status

Active, not recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-10-16

Anticipated Date of Last Follow-up
2025-06-20

Estimated Primary Completion Date
2026-05-01

Estimated Completion Date
2029-07-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2029-07-01

Studied populations

Age Cohort

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

Interventional (clinical trial)

Enrollment

150

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Identifier

NCT03987919

Link

https://clinicaltrials.gov/study/NCT03987919

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Semaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-07-30

Anticipated Date of Last Follow-up
2022-01-21

Estimated Primary Completion Date
2021-01-28 00:00:00

Estimated Completion Date
2021-02-15 00:00:00

Actual Primary Completion Date
2021-01-28

Actual Completion Date
2021-02-15

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

Interventional (clinical trial)

Enrollment

1879

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Identifier

NCT04039503

Link

https://clinicaltrials.gov/study/NCT04039503

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-08-30

Anticipated Date of Last Follow-up
2021-12-12

Estimated Primary Completion Date
2020-12-22 00:00:00

Estimated Completion Date
2021-01-13 00:00:00

Actual Primary Completion Date
2020-12-22

Actual Completion Date
2021-01-13

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

Interventional (clinical trial)

Enrollment

475

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Identifier

NCT04050553

Link

https://clinicaltrials.gov/study/NCT04050553

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-02-24

Anticipated Date of Last Follow-up
2023-12-07

Estimated Primary Completion Date
2022-01-25 00:00:00

Estimated Completion Date
2022-01-25 00:00:00

Actual Primary Completion Date
2022-01-25

Actual Completion Date
2022-01-25

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

Interventional (clinical trial)

Enrollment

42

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS)

Identifier

NCT05260021

Link

https://clinicaltrials.gov/study/NCT05260021

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

Interventions

Intervention 1

Tirzepatide Dose 1

Intervention 2

Tirzepatide Dose 2

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-04-13

Anticipated Date of Last Follow-up
2025-09-08

Estimated Primary Completion Date
2024-07-30

Estimated Completion Date
2025-01-28

Actual Primary Completion Date
2024-07-30

Actual Completion Date
2025-01-28

Studied populations

Age Cohort

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

Interventional (clinical trial)

Enrollment

99

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Identifier

NCT05564039

Link

https://clinicaltrials.gov/study/NCT05564039

Phase

Marketed

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Dulaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-11-30

Anticipated Date of Last Follow-up
2025-07-15

Estimated Primary Completion Date
2024-07-15 00:00:00

Estimated Completion Date
2024-08-12 00:00:00

Actual Primary Completion Date
2024-07-15

Actual Completion Date
2024-08-12

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

Interventional (clinical trial)

Enrollment

282

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of LY3841136 in Overweight and Obese Participants

Identifier

NCT06345066

Link

https://clinicaltrials.gov/study/NCT06345066

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

LY3841136

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-04-03

Anticipated Date of Last Follow-up
2025-10-14

Estimated Primary Completion Date
2025-10-01 00:00:00

Estimated Completion Date
2025-10-01 00:00:00

Actual Primary Completion Date
2025-09-29

Actual Completion Date
2025-09-29

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

Interventional (clinical trial)

Enrollment

96

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Overweight and Very Overweight Participants

Identifier

NCT04311411

Link

https://clinicaltrials.gov/study/NCT04311411

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Intervention 3

Liraglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-08-24

Anticipated Date of Last Follow-up
2024-05-21

Estimated Primary Completion Date
2022-12-16 00:00:00

Estimated Completion Date
2022-12-16 00:00:00

Actual Primary Completion Date
2022-12-16

Actual Completion Date
2022-12-16

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

Interventional (clinical trial)

Enrollment

114

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of LY3457263 in Obese Participants

Identifier

NCT05582096

Link

https://clinicaltrials.gov/study/NCT05582096

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

LY3457263

Intervention 2

Tirzepatide

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-11-11

Anticipated Date of Last Follow-up
2023-07-17

Estimated Primary Completion Date
2023-06-08 00:00:00

Estimated Completion Date
2023-06-08 00:00:00

Actual Primary Completion Date
2023-06-08

Actual Completion Date
2023-06-08

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

Interventional (clinical trial)

Enrollment

38

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Identifier

NCT04093752

Link

https://clinicaltrials.gov/study/NCT04093752

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Insulin Glargine

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-12-09

Anticipated Date of Last Follow-up
2022-12-12

Estimated Primary Completion Date
2021-11-01 00:00:00

Estimated Completion Date
2021-11-24 00:00:00

Actual Primary Completion Date
2021-11-01

Actual Completion Date
2021-11-24

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

Interventional (clinical trial)

Enrollment

917

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

Identifier

NCT04172987

Link

https://clinicaltrials.gov/study/NCT04172987

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

EE/NGM

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-02-26

Anticipated Date of Last Follow-up
2022-06-09

Estimated Primary Completion Date
2021-02-09 00:00:00

Estimated Completion Date
2021-02-09 00:00:00

Actual Primary Completion Date
2021-02-09

Actual Completion Date
2021-02-09

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

Interventional (clinical trial)

Enrollment

40

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Identifier

NCT05536804

Link

https://clinicaltrials.gov/study/NCT05536804

Phase

Phase II

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-02-08

Anticipated Date of Last Follow-up
2025-09-26

Estimated Primary Completion Date
2026-09-01

Estimated Completion Date
2026-10-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-10-01 00:00:00

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

Observational studies (incl. patient registries)

Enrollment

140

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

Identifier

NCT05412004

Link

https://clinicaltrials.gov/study/NCT05412004

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-06-21

Anticipated Date of Last Follow-up
2025-04-12

Estimated Primary Completion Date
2024-03-12 00:00:00

Estimated Completion Date
2024-03-29 00:00:00

Actual Primary Completion Date
2024-03-12

Actual Completion Date
2024-03-29

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

Interventional (clinical trial)

Enrollment

469

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Identifier

NCT02759107

Link

https://clinicaltrials.gov/study/NCT02759107

Phase

Phase I

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Placebo

Intervention 3

Dulaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-05-11

Anticipated Date of Last Follow-up
2023-04-17

Estimated Primary Completion Date
2017-06-26 00:00:00

Estimated Completion Date
2017-06-26 00:00:00

Actual Primary Completion Date
2017-06-26

Actual Completion Date
2017-06-26

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

Interventional (clinical trial)

Enrollment

142

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study.

Identifier

NCT06354101

Link

https://clinicaltrials.gov/study/NCT06354101

Phase

Phase I

Status

Withdrawn

Sponsor

CorEvitas

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Semaglutide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-07-01

Anticipated Date of Last Follow-up
2024-04-08

Estimated Primary Completion Date
2023-07-01 00:00:00

Estimated Completion Date
2023-07-01 00:00:00

Actual Primary Completion Date
2023-07-01

Actual Completion Date
2023-07-01

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

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity

Identifier

NCT06916065

Link

https://clinicaltrials.gov/study/NCT06916065

Phase

Phase I

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Eloralintide and Tirzepatide

Intervention 2

Eloralintide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-04-09

Anticipated Date of Last Follow-up
2025-11-21

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2025-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2025-12-01 00:00:00

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

Interventional (clinical trial)

Enrollment

204

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

Identifier

NCT03951753

Link

https://clinicaltrials.gov/study/NCT03951753

Phase

Phase II

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Semaglutide

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-06-28

Anticipated Date of Last Follow-up
2022-06-08

Estimated Primary Completion Date
2021-04-08 00:00:00

Estimated Completion Date
2021-04-08 00:00:00

Actual Primary Completion Date
2021-04-08

Actual Completion Date
2021-04-08

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

Interventional (clinical trial)

Enrollment

117

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Identifier

NCT06603571

Link

https://clinicaltrials.gov/study/NCT06603571

Phase

Phase III

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

LY3841136

Intervention 2

Tirzepatide

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-09-20

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

Estimated Primary Completion Date
2026-06-01

Estimated Completion Date
2026-08-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-08-01 00:00:00

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

Interventional (clinical trial)

Enrollment

350

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

Identifier

NCT03882970

Link

https://clinicaltrials.gov/study/NCT03882970

Phase

Phase II

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Insulin Degludec

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-04-01

Anticipated Date of Last Follow-up
2022-01-14

Estimated Primary Completion Date
2020-12-11 00:00:00

Estimated Completion Date
2021-01-04 00:00:00

Actual Primary Completion Date
2020-12-11

Actual Completion Date
2021-01-04

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

Interventional (clinical trial)

Enrollment

1444

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus

Identifier

NCT03131687

Link

https://clinicaltrials.gov/study/NCT03131687

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

tirzepatide

Intervention 2

Dulaglutide

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-05-24

Anticipated Date of Last Follow-up
2019-07-31

Estimated Primary Completion Date
2018-08-01 00:00:00

Estimated Completion Date
2018-08-01 00:00:00

Actual Primary Completion Date
2018-08-01

Actual Completion Date
2018-08-01

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

Interventional (clinical trial)

Enrollment

318

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Identifier

NCT03730662

Link

https://clinicaltrials.gov/study/NCT03730662

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Insulin Glargine

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-11-20

Anticipated Date of Last Follow-up
2022-01-21

Estimated Primary Completion Date
2021-01-22 00:00:00

Estimated Completion Date
2021-04-22 00:00:00

Actual Primary Completion Date
2021-01-22

Actual Completion Date
2021-04-22

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

Interventional (clinical trial)

Enrollment

2002

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Identifier

NCT06937099

Link

https://clinicaltrials.gov/study/NCT06937099

Phase

Phase III

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Mirikizumab

Intervention 2

Mirikizumab

Intervention 3

Tirzepatide

Intervention 4

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-06-26

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2028-05-01

Estimated Completion Date
2028-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2028-05-01 00:00:00

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

Interventional (clinical trial)

Enrollment

290

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Identifier

NCT06937086

Link

https://clinicaltrials.gov/study/NCT06937086

Phase

Marketed

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Mirikizumab

Intervention 2

Mirikizumab

Intervention 3

Tirzepatide

Intervention 4

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-06-26

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2028-04-01

Estimated Completion Date
2028-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2028-04-01 00:00:00

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

Interventional (clinical trial)

Enrollment

350

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Identifier

NCT05433584

Link

https://clinicaltrials.gov/study/NCT05433584

Phase

Phase II

Status

Not provided

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Antihyperglycemic medication

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-08-01

Anticipated Date of Last Follow-up
2025-04-17

Estimated Primary Completion Date
2025-10-01

Estimated Completion Date
2027-11-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-11-01 00:00:00

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

Interventional (clinical trial)

Enrollment

780

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over

Identifier

NCT06515418

Link

https://clinicaltrials.gov/study/NCT06515418

Phase

Phase III

Status

Terminated

Sponsor

BioAge Labs, Inc.

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Oral Azelaprag (BGE-105)

Intervention 2

Oral Placebo for Azelaprag (BGE-105)

Intervention 3

Tirzepatide

Intervention 4

Tirzepatide Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-06-27

Anticipated Date of Last Follow-up
2025-03-11

Estimated Primary Completion Date
2025-02-06 00:00:00

Estimated Completion Date
2025-02-12 00:00:00

Actual Primary Completion Date
2025-02-06

Actual Completion Date
2025-02-12

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

Interventional (clinical trial)

Enrollment

204

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Identifier

NCT03861039

Link

https://clinicaltrials.gov/study/NCT03861039

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Oral antihyperglycemic medication (OAM)

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-03-30

Anticipated Date of Last Follow-up
2022-01-21

Estimated Primary Completion Date
2021-01-26 00:00:00

Estimated Completion Date
2021-02-16 00:00:00

Actual Primary Completion Date
2021-01-26

Actual Completion Date
2021-02-16

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

Interventional (clinical trial)

Enrollment

443

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

Identifier

NCT04537923

Link

https://clinicaltrials.gov/study/NCT04537923

Phase

Phase III

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Insulin Lispro (U100)

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-10-19

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

Estimated Primary Completion Date
2022-10-11 00:00:00

Estimated Completion Date
2022-11-01 00:00:00

Actual Primary Completion Date
2022-10-11

Actual Completion Date
2022-11-01

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

Interventional (clinical trial)

Enrollment

1428

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Identifier

NCT07165028

Link

https://clinicaltrials.gov/study/NCT07165028

Phase

Phase I

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Retatrutide

Intervention 3

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-10-15

Anticipated Date of Last Follow-up
2025-12-03

Estimated Primary Completion Date
2030-08-01

Estimated Completion Date
2032-08-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2032-08-01 00:00:00

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

Interventional (clinical trial)

Enrollment

4500

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Single blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

Identifier

NCT05810597

Link

https://clinicaltrials.gov/study/NCT05810597

Phase

Phase II

Status

Completed

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Single Dose Pen

Intervention 3

Multi-use Prefilled Pen

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-04-03

Anticipated Date of Last Follow-up
2024-07-17

Estimated Primary Completion Date
2023-07-17 00:00:00

Estimated Completion Date
2023-07-17 00:00:00

Actual Primary Completion Date
2023-07-17

Actual Completion Date
2023-07-17

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

Interventional (clinical trial)

Enrollment

65

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Identifier

NCT06143956

Link

https://clinicaltrials.gov/study/NCT06143956

Phase

Phase II

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

LY3305677

Intervention 2

LY3841136

Intervention 3

Tirzepatide

Intervention 4

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-17

Anticipated Date of Last Follow-up
2025-11-19

Estimated Primary Completion Date
2026-06-01

Estimated Completion Date
2026-09-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2026-11-01 00:00:00

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

Interventional (clinical trial)

Enrollment

1217

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

Identifier

NCT06847399

Link

https://clinicaltrials.gov/study/NCT06847399

Phase

Marketed

Status

Recruiting

Sponsor

Johns Hopkins University

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Tirzepatide

Intervention 2

Lisdexamfetamine Dimesylate

Intervention 3

Guided self-help cognitive behavioral therapy

Intervention 4

Placebo (oral)

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-09-17

Anticipated Date of Last Follow-up
2025-09-17

Estimated Primary Completion Date
2027-12-01

Estimated Completion Date
2027-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-12-01 00:00:00

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

105

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

Identifier

NCT06009653

Link

https://clinicaltrials.gov/study/NCT06009653

Phase

Phase II

Status

Withdrawn

Sponsor

Washington University School of Medicine

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

Standard Care

Intervention 2

Culturally-tailored dietary and behavioral intensive lifestyle intervention

Intervention 3

Placebo

Intervention 4

Tirzepatide

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-09-13

Anticipated Date of Last Follow-up
2025-02-21

Estimated Primary Completion Date
2024-05-29 00:00:00

Estimated Completion Date
2024-05-29 00:00:00

Actual Primary Completion Date
2024-05-29

Actual Completion Date
2024-05-29

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

Not provided

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

Identifier

NCT06897475

Link

https://clinicaltrials.gov/study/NCT06897475

Phase

Phase II

Status

Recruiting

Sponsor

Eli Lilly and Company

More details

Not provided

Purpose

Not provided

Interventions

Intervention 1

LY3457263

Intervention 2

Placebo

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-03-28

Anticipated Date of Last Follow-up
2025-10-15

Estimated Primary Completion Date
2026-12-01

Estimated Completion Date
2027-01-01

Actual Primary Completion Date
Not provided

Actual Completion Date
2027-01-01 00:00:00

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

240

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Other/Variable/Unknown : "Once weekly "

Studied LA-formulation(s)

Other(s)

Studied route(s) of administration

Subcutaneous

Use case

Treatment

Key resources

Not provided

Excipients

Proprietary excipients used

No proprietary excipient used

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

Sodium chloride (NaCl), sodium phosphate dibasic heptahydrate (Na₂HPO₄·7H₂O), water for injection (WFI), HCL solution, and/or NaOH solution.

Residual solvents used

No residual solvent used

Patent info

Formulation patent families

Patent informations
Patent description Representative patent Categories Patent holder Licence with MPP Patent source
Tirzepatide liquid formulations
Expiry date: 2039-06-14
A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided. 		WO2019245893 Composition Eli Lilly And Company No
Patent status
Patent status/countries Low, Low- middle and upper-middle High income
Granted China, Armenia, Kazakhstan, Morocco, Tunisia, Albania, Serbia, Bosnia and Herzegovina, Cambodia, Montenegro, Türkiye, Moldova, Republic of, North Macedonia, Peru, India, Algeria, Namibia, Ghana, Botswana, Kenya, South Africa, Indonesia, Colombia Australia, Chile, Russian Federation, Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Bulgaria, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Monaco, Sweden, Japan, Korea, Republic of, Taiwan, Province of China, United States of America, New Zealand, Hong Kong
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Patent informations
Patent description Representative patent Categories Patent holder Licence with MPP Patent source
Tirzepatide compound and analogues
Expiry date: 2036-01-05
The present invention relates to dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), and may be useful for treating type 2 diabetes mellitus (T2D). 		WO2016111971 Compound Eli Lilly And Company No
Patent status
Patent status/countries Low, Low- middle and upper-middle High income
Granted Argentina, Brazil, China, Colombia, Dominican Republic, Tajikistan, Belarus, Azerbaijan, Turkmenistan, Armenia, Kyrgyzstan, Kazakhstan, Morocco, Serbia, Bosnia and Herzegovina, Montenegro, Türkiye, Moldova, Republic of, North Macedonia, Mexico, Malaysia, Peru, Philippines, El Salvador, Ukraine, South Africa, India, Namibia, Ghana, Botswana, Kenya, Indonesia, Thailand, Viet Nam Australia, Chile, Costa Rica, Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Bulgaria, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Monaco, Sweden, Israel, Japan, Korea, Republic of, New Zealand, United States of America, Kuwait, United Arab Emirates, Bahrain, Saudi Arabia, Oman, Qatar, Hong Kong, Trinidad and Tobago
Filed Argentina, Tajikistan, Belarus, Azerbaijan, Turkmenistan, Armenia, Kyrgyzstan, Kazakhstan, Ecuador, Morocco, Albania, Serbia, Bosnia and Herzegovina, Montenegro, Türkiye, Moldova, Republic of, North Macedonia, Jordan, Mexico, Tunisia, Egypt, Guatemala, Honduras, Lebanon, Pakistan, Sri Lanka, Venezuela (Bolivarian Republic of) Canada, Russian Federation, Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, San Marino, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Bulgaria, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Monaco, Sweden, Israel, Korea, Republic of, Singapore, Taiwan, Province of China, Brunei Darussalam, Macao, Panama
Not in force World Intellectual Property Organization (WIPO), Tajikistan, Belarus, Azerbaijan, Turkmenistan, Armenia, Kyrgyzstan, Kazakhstan, Albania, Sierra Leone, Eswatini, Liberia, Sao Tome and Principe, Mozambique, Uganda, Zambia, Zimbabwe, Tanzania, United Republic of, Malawi, Rwanda, Sudan, Lesotho, Gambia (the) World Intellectual Property Organization (WIPO), Russian Federation, San Marino, Korea, Republic of

Supporting material

Publications

Garvey, W. T., Frias, J. P., Jastreboff, A. M., le Roux, C. W., Sattar, N., Aizenberg, D., Mao, H., Zhang, S., Ahmad, N. N., Bunck, M. C., Benabbad, I., Zhang, X. M., & SURMOUNT-2 investigators (2023). Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet (London, England), 402(10402), 613–626. https://doi.org/10.1016/S0140-6736(23)01200-X

Background: Weight reduction is essential for improving health outcomes in people with obesity and type 2 diabetes. We assessed the efficacy and safety of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, versus placebo, for weight management in people living with obesity and type 2 diabetes.

Methods: This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries. Adults (aged ≥18 years) with a body-mass index (BMI) of 27 kg/m2 or higher and glycated haemoglobin (HbA1c) of 7-10% (53-86 mmol/mol) were randomly assigned (1:1:1), using a computer-generated random sequence via a validated interactive web-response system, to receive either once-weekly, subcutaneous tirzepatide (10 mg or 15 mg) or placebo for 72 weeks. All participants, investigators, and the sponsor were masked to treatment assignment. Coprimary endpoints were the percent change in bodyweight from baseline and bodyweight reduction of 5% or higher. The treatment-regimen estimand assessed effects regardless of treatment discontinuation or initiation of antihyperglycaemic rescue therapy. Efficacy and safety endpoints were analysed with data from all randomly assigned participants (intention-to-treat population). This trial is registered with ClinicalTrials.gov, NCT04657003.

Findings: Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide 15 mg (n=311), or placebo (n=315). Baseline mean bodyweight was 100·7 kg (SD 21·1), BMI 36·1 kg/m2 (SD 6·6), and HbA1c 8·02% (SD 0·89; 64·1 mmol/mol [SD 9·7]). Least-squares mean change in bodyweight at week 72 with tirzepatide 10 mg and 15 mg was -12·8% (SE 0·6) and -14·7% (0·5), respectively, and -3·2% (0·5) with placebo, resulting in estimated treatment differences versus placebo of -9·6% percentage points (95% CI -11·1 to -8·1) with tirzepatide 10 mg and -11·6% percentage points (-13·0 to -10·1) with tirzepatide 15 mg (all p<0·0001). More participants treated with tirzepatide versus placebo met bodyweight reduction thresholds of 5% or higher (79-83% vs 32%). The most frequent adverse events with tirzepatide were gastrointestinal-related, including nausea, diarrhoea, and vomiting and were mostly mild to moderate in severity, with few events leading to treatment discontinuation (<5%). Serious adverse events were reported by 68 (7%) participants overall and two deaths occurred in the tirzepatide 10 mg group, but deaths were not considered to be related to the study treatment by the investigator.

Interpretation: In this 72-week trial in adults living with obesity and type 2 diabetes, once-weekly tirzepatide 10 mg and 15 mg provided substantial and clinically meaningful reduction in bodyweight, with a safety profile that was similar to other incretin-based therapies for weight management.

Osumili, B., Sapin, H., Yang, Z., Ranta, K., Paik, J. S., & Blüher, M. (2025). Efficacy and Safety of Tirzepatide Compared with GLP-1 RAs in Patients with Type 2 Diabetes Treated with Basal Insulin: A Network Meta-analysis. Diabetes therapy : research, treatment and education of diabetes and related disorders, 16(6), 1279–1311. https://doi.org/10.1007/s13300-025-01728-5

Introduction: The relative efficacy and safety of tirzepatide was compared with glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes mellitus (T2DM) treated with basal insulin using a network meta-analysis (NMA).

Methods: A systematic literature review was performed to identify randomized controlled trials of GLP-1 RAs in patients with T2DM treated with insulin and an antihyperglycaemic drug. For the NMA, studies included trials with 100% of patients treated with basal insulin background therapy with a titration scheme comparable to the SURPASS-5 trial. The following data were extracted for efficacy and safety assessment at the primary endpoint of each study: changes from baseline in glycated haemoglobin (HbA1c) and body weight and the incidence of nausea, vomiting or diarrhoea, hypoglycaemia, and patients discontinuing treatment because of adverse events. In this study, a comparative analysis of tirzepatide was performed with the GLP-1 RAs dulaglutide, exenatide, and lixisenatide in addition to placebo.

Results: A total of six studies were included across the analyses. Tirzepatide 5, 10, and 15 mg showed statistically significant, greater reductions in HbA1c and body weight at the primary endpoint versus all GLP-1 RA comparators and placebo. Tirzepatide 5, 10, and 15 mg showed a statistically significant, higher likelihood of experiencing nausea compared with those who received placebo or exenatide 2 mg; no statistically significant differences were observed when compared with all other GLP-1 RA comparators. No statistically significant differences were observed in the proportions of patients who discontinued treatment because of adverse events when tirzepatide 5, 10, and 15 mg were compared with GLP-1 RA comparators, apart from tirzepatide 10 and 15 mg versus placebo.

Conclusion: Tirzepatide demonstrated statistically significantly greater reductions in HbA1c and body weight when compared with selected GLP-1 RAs and placebo in patients with T2DM treated with basal insulin. Overall, the safety profile of tirzepatide was similar to that of GLP-1RAs.

Martin, C. K., Carmichael, O. T., Carnell, S., Considine, R. V., Kareken, D. A., Dydak, U., Mattes, R. D., Scott, D., Shcherbinin, S., Nishiyama, H., Knights, A., Urva, S., Biernat, L., Pratt, E., Haupt, A., Mintun, M., Otero Svaldi, D., Milicevic, Z., & Coskun, T. (2025). Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial. Nature medicine, 10.1038/s41591-025-03774-9. Advance online publication. https://doi.org/10.1038/s41591-025-03774-9

Tirzepatide induces weight reduction but the underlying mechanisms are unknown. This 6-week phase 1 study investigated early effects of tirzepatide on energy intake. Male and female adults without diabetes (n = 114) and a body mass index from 27 to 50 kg per m2 were randomized 1:1:1 to blinded once-weekly tirzepatide or placebo, or open-label once-daily liraglutide. The primary outcome was change from baseline to week 3 in energy intake during an ad libitum lunch with tirzepatide versus placebo. Secondary outcomes assessed self-reported ingestive behavior and blood-oxygenation-level-dependent functional magnetic resonance imaging with food photos. Tirzepatide reduced energy intake versus placebo at week 3 (estimated treatment difference -524.6 kcal (95% confidence interval -648.1 to -401.0), P < 0.0001). With regard to secondary outcomes versus placebo, tirzepatide decreased overall appetite, food cravings, tendency to overeat, perceived hunger and reactivity to foods in the environment but did not impact volitional restriction of dietary intake. At week 3 versus placebo, tirzepatide did not statistically significantly impact blood-oxygenation-level-dependent activation to highly palatable food photos (aggregated category of high-fat, high-sugar foods and high-fat, high-carbohydrate foods) but decreased activation to high-fat, high-sugar food photos in the medial frontal and cingulate gyri, orbitofrontal cortex and hippocampus. Our results suggest tirzepatide reduces food intake, potentially by impacting ingestive behavior. ClinicalTrials.gov registration: NCT04311411 .

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