A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity

April 15, 2026 updated by: Eli Lilly and Company

A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity

The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117-5116
        • Recruiting
        • Fortrea Clinical Research Unit - Daytona Beach
        • Principal Investigator:
          • Kathleen Doisy
        • Contact:
          • Phone Number: 866-429-3700
    • Texas
      • Dallas, Texas, United States, 75247
        • Recruiting
        • Fortrea Clinical Research Unit
        • Principal Investigator:
          • Gene Voskuhl
        • Contact:
          • Phone Number: 866-429-3700
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Recruiting
        • Fortrea Clinical Research Unit Inc. - Madison
        • Principal Investigator:
          • Kimberly Cruz
        • Contact:
          • Phone Number: 866-429-3700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation
  • Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg/m^2)
  • Have no significant (not more than 5 percent [%]) self-reported weight gain or loss in the past 3 months prior to screening

Exclusion Criteria:

  • Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data
  • Have a prior diagnosis of type 1 or type 2 diabetes mellitus
  • Have a history of acute or chronic pancreatitis
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
  • Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, GIP/GLP-1/glucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening
  • Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal/nutritional supplements), that promote weight loss within 6 months prior to screening
  • Are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo administered SC.
Other: Placebo
Administered SC.
Experimental: Brenipatide
Participants will receive brenipatide subcutaneously (SC).
Drug: Brenipatide
Administered SC.
Other Names:
  • LY3537031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Body Weight
Time Frame: Week 1, Week 29
Week 1, Week 29

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants who discontinued due to an Adverse Events (AEs)
Time Frame: Day 1 through Week 37
Day 1 through Week 37
Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs
Time Frame: Day 1 through Week 37
Day 1 through Week 37
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide
Time Frame: Pre-dose on Day 1 through Week 37
Pre-dose on Day 1 through Week 37
PK: Maximum Concentration (Cmax) of Brenipatide
Time Frame: Pre-dose on Day 1 through Week 37
Pre-dose on Day 1 through Week 37
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight
Time Frame: Week 29
Week 29
Change in Waist Circumference
Time Frame: Week 1, Week 29
Week 1, Week 29
Change in Waist-to-Height Ratio
Time Frame: Week 1, Week 29
Week 1, Week 29
Change in Blood Pressure
Time Frame: Week 1, Week 29
Week 1, Week 29
Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)
Time Frame: Week 1, Week 29
Week 1, Week 29
Change in High-sensitive C-reactive Protein (hsCRP)
Time Frame: Week 1, Week 29
Week 1, Week 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27802
  • J2S-MC-GZMU (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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