Brenipatide injections for adults 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
This trial will try different doses of brenipatide given as under-the-skin injections to see how well they work and whether they are safe for adults with overweight or obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 3 sites (Daytona Beach, Florida and 2 other locations) |
| Trial ID | NCT07476118 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study tests multiple dose levels of brenipatide administered by subcutaneous injection in adults with overweight or obesity (BMI 27.0–45.0 kg/m2) who are otherwise healthy. Participants will be followed for about 42 weeks while receiving active drug or placebo to characterize safety, tolerability, and pharmacologic effects. Key exclusions include diabetes, significant organ disorders, recent substantial weight change, history of pancreatitis, and personal or family history of medullary thyroid carcinoma. Data collected will include adverse events, laboratory measures, and drug exposure metrics to inform dosing for later trials.
Who should consider this trial
Good fit: Ideal candidates are adults with BMI 27.0–45.0 kg/m2 who are otherwise healthy (no diabetes or major organ disease) and have had less than 5% weight change in the prior 3 months.
Not a fit: People with type 1 or type 2 diabetes, a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disease are excluded and unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, brenipatide could move into later trials and potentially become a new injectable option to help people with overweight or obesity manage weight.
How similar studies have performed: Other injectable peptide approaches for weight loss (for example GLP‑1 receptor agonists) have shown substantial weight loss in later‑phase trials, so the general approach has precedent, but brenipatide itself is still early‑stage and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Daytona Beach, Florida and 2 other locations
- Fortrea Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States (Recruiting)
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Recruiting)
- Fortrea Clinical Research Unit Inc. - Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.