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Clinical Trials in the USA / NCT07476118
Active, not recruiting Phase 1

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

NCT07476118 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2026-03-18
Last updated
2026-07-16

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Brenipatide →Placebo

Brenipatide: Administered SC.

Placebo: Administered SC.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Fortrea Clinical Research Unit - Daytona Beach Daytona Beach Florida
Fortrea Clinical Research Unit Dallas Texas
Fortrea Clinical Research Unit Inc. - Madison Madison Wisconsin

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07476118 on ClinicalTrials.gov ↗ ← All trials in the USA