Active not recruitingPhase 1

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

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

150

Study population

Obesity / overweight

Eligibility highlights

•Healthy volunteers

Primary endpoint

•Body Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07476118

Org study ID27802

Secondary IDJ2S-MC-GZMUEli Lilly and Company

Timeline

Milestones

Study first posted2026-03-17actual

Study start2026-03-18actual

Last update posted2026-07-16actual

Primary completion2027-02estimated (month precision)

Study completion2027-02estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percent Change in Body Weight

Time frame:Week 1, Week 29

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 5% Reduction in Body Weight

Time frame:Week 29