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NOT_YET_RECRUITINGPHASE1

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

NCT07476118•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

March 17, 2026

Enrollment

150

ESTIMATED participants

Conditions

ObesityOverweight

Interventions

Brenipatide

DRUG

Placebo

OTHER

Contacts

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

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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