Skip to main content
MedPathMedPath Home
Clinical Trials/NCT07476118
NCT07476118
Recruiting
Phase 1

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

Eli Lilly and Company6 sites in 1 country150 target enrollmentStarted: March 18, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
InterventionsBrenipatidePlacebo

Overview

Phase
Phase 1
Status
Recruiting
Enrollment
150
Locations
6
Primary Endpoint
Percent Change in Body Weight
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Brenipatide

Experimental

Participants will receive brenipatide subcutaneously (SC).

Intervention: Brenipatide (Drug)

Placebo

Placebo Comparator

Participants will receive placebo administered SC.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Percent Change in Body Weight

Time Frame: Week 1, Week 29

Secondary Outcomes

  • 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)
  • Change in Waist Circumference(Week 1, Week 29)
  • Change in Waist-to-Height Ratio(Week 1, Week 29)
  • Change in Blood Pressure(Week 1, Week 29)
  • Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)(Week 1, Week 29)
  • Change in High-sensitive C-reactive Protein (hsCRP)(Week 1, Week 29)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

Loading locations...

Similar Trials

Recruiting
Phase 2
A Study of Brenipatide in Adult Participants With Schizophrenia
NCT07410507Eli Lilly and Company450
Recruiting
Phase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
NCT07286175Eli Lilly and Company400
Not yet recruiting
Phase 3
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
2025-522313-38-00Eli Lilly & Co.47
Recruiting
Phase 2
A Study of Brenipatide in Participants With Opioid Use Disorder
NCT07420283Eli Lilly and Company465
Recruiting
Phase 3
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
NCT07412756Eli Lilly and Company1,000