NCT07476118

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1 obesity

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

March 13, 2026

Last Update Submit

April 15, 2026

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Body Weight

    Week 1, Week 29

Secondary Outcomes (10)

  • Number of Participants who discontinued due to an Adverse Events (AEs)

    Day 1 through Week 37

  • Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs

    Day 1 through Week 37

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide

    Pre-dose on Day 1 through Week 37

  • PK: Maximum Concentration (Cmax) of Brenipatide

    Pre-dose on Day 1 through Week 37

  • Percentage of Participants Achieving ≥ 5% Reduction in Body Weight

    Week 29

  • +5 more secondary outcomes

Study Arms (2)

Brenipatide

EXPERIMENTAL

Participants will receive brenipatide subcutaneously (SC).

Drug: Brenipatide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo administered SC.

Other: Placebo

Interventions

BrenipatideDRUG

Administered SC.

Also known as: LY3537031
Brenipatide
PlaceboOTHER

Administered SC.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)