NCT07476118Active, not recruitingPhase 1
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
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 · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 13 Mar 2026
- Start date
- 18 Mar 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT07476118
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 18 Mar 2026 to the primary completion date, Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a prior diagnosis of type 1 or type 2 diabetes mellitus
- 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
Other illness
- 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 history of acute or chronic pancreatitis
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Lab values
- 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
Other
- Are pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fortrea Clinical Research Unit Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Fortrea Clinical Research Unit - Daytona Beach Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Fortrea Clinical Research Unit Inc. - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.