> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-brenipatide-ly3537031-in-healthy-participants-0cd50525-2d5b-40ec-9c2d-c019efcbd546 > Record changed: 2026-11-04 # A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity NCT07476118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Start date 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Short title** A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Dates **Completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **First posted** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Primary completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Start date** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Identifiers **Registry ID** NCT07476118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **ClinicalTrials.gov ID** NCT07476118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Outcomes ### Primary outcomes 1. Percent Change in Body Weight Timeframe: Week 1, Week 29 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## References ### Other registry identifiers - J2S-MC-GZMU Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07476118) ## Related records ### Drugs (1) - [Brenipatide](https://trialight.com/data/asset/brenipatide-4758d77a-80b3-5d20-93d3-fc5bfaf5857c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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