Olatorepatide for adults with overweight or obesity in the U.S.
A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US
This study will test olatorepatide in adults with overweight or obesity who do not have diabetes to see if it helps reduce body weight and is safe and well tolerated.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 3 sites (Walnut Creek, California and 2 other locations) |
| Trial ID | NCT07431086 on ClinicalTrials.gov |
What this trial studies
Olatorepatide is an investigational medicine related to GLP‑1/GIP mechanisms being given to adults with BMI 27.0 to <45.0 kg/m2 who do not have diabetes. Participants receive olatorepatide or placebo and are followed for safety, tolerability, body weight and waist circumference, blood drug levels (pharmacokinetics), and antibody formation against the drug. The trial excludes people with recent large weight changes, prior bariatric surgery, diabetes, pancreatitis, symptomatic gallbladder disease, or recent significant malignancy. Conducted at several outpatient research clinics in the U.S., this phase 2 study is intended to define safety and preliminary effectiveness to inform later trials.
Who should consider this trial
Good fit: Adults in the U.S. with BMI between 27.0 and <45.0 kg/m2 without type 1 or type 2 diabetes who can attend scheduled clinic visits and follow the protocol may be eligible.
Not a fit: People with diabetes, recent weight changes greater than 5 kg, prior or planned bariatric surgery, a history of pancreatitis or symptomatic gallbladder disease, or recent significant cancer are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, olatorepatide could help adults with overweight or obesity lose clinically meaningful weight while being generally well tolerated.
How similar studies have performed: Other drugs that act on GLP‑1 and GIP pathways have produced substantial weight loss in similar patient populations, so this mechanism has precedent for effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Body mass index ≥27.0 kg/m\^2 to \<45.0 kg/m\^2 at screening 2. Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment Key Exclusion Criteria: 1. History of Type 1 or Type 2 diabetes 2. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol 3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period 4. History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Where this trial is running
Walnut Creek, California and 2 other locations
- Diablo Clinical Research - Flourish Research — Walnut Creek, California, United States (Recruiting)
- Clinical Site Partners, LLC DBA Flourish Research — Winter Park, Florida, United States (Recruiting)
- Flourish Research - San Antonio Medical Trials — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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.