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

NCT07476118
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
150
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Lead sponsor
Eli Lilly and Company
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Start date
2026-03-18
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Number of sites
3
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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.
clinicaltrials.gov
Short title
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
clinicaltrials.gov
Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-02-01
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First posted
2026-03-17
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Registry last updated
2026-07-16
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Primary completion date
2027-02-01
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Start date
2026-03-18
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Participants
150
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Participant count basis
Estimated
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Planned participants
150
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Protocol amendments
0
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Number of sites
3
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07476118
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ClinicalTrials.gov ID
NCT07476118
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change in Body Weight

    Timeframe: Week 1, Week 29

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

    Timeframe: Day 1 through Week 37

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

    Timeframe: Day 1 through Week 37

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

    Timeframe: Pre-dose on Day 1 through Week 37

  4. PK: Maximum Concentration (Cmax) of Brenipatide

    Timeframe: Pre-dose on Day 1 through Week 37

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

    Timeframe: Week 29

  6. Change in Waist Circumference

    Timeframe: Week 1, Week 29

  7. Change in Waist-to-Height Ratio

    Timeframe: Week 1, Week 29

  8. Change in Blood Pressure

    Timeframe: Week 1, Week 29

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

    Timeframe: Week 1, Week 29

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

    Timeframe: Week 1, Week 29

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, United States
  • Fortrea Clinical Research UnitDallas, United States
  • Fortrea Clinical Research Unit Inc. - MadisonMadison, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2S-MC-GZMU
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)