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NCT Number: NCT07476118

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit - Daytona Beach, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brenipatide

Drug

Administered SC.

Other names: LY3537031

Placebo

Other

Administered SC.

Primary outcomes

  1. Percent Change in Body Weight

    Time frame: Week 1, Week 29

Secondary outcomes

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

    Time frame: Day 1 through Week 37

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

    Time frame: Day 1 through Week 37

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

    Time frame: Pre-dose on Day 1 through Week 37

  4. PK: Maximum Concentration (Cmax) of Brenipatide

    Time frame: Pre-dose on Day 1 through Week 37

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

    Time frame: Week 29

  6. Change in Waist Circumference

    Time frame: Week 1, Week 29

  7. Change in Waist-to-Height Ratio

    Time frame: Week 1, Week 29

  8. Change in Blood Pressure

    Time frame: Week 1, Week 29

  9. Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)

    Time frame: Week 1, Week 29

  10. Change in High-sensitive C-reactive Protein (hsCRP)

    Time frame: Week 1, Week 29

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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