Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07476118

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

Led by Eli Lilly and Company · Updated on 2026-04-20

150

Participants Needed

3

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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/m²)
  • Have no significant (not more than 5 percent [%]) self-reported weight gain or loss in the past 3 months prior to screening
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States, 32117-5116

Actively Recruiting

2

Fortrea Clinical Research Unit

Dallas, Texas, United States, 75247

Actively Recruiting

3

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States, 53704

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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