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
Regeneron Pharmaceuticals
Summary
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much the study drug is in the blood at different times * How well the study drug works * If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 ran…
Interventions
- DrugOlatorepatide
Administered per the protocol
- DrugPlacebo
Administered per the protocol
Locations (3)
- Diablo Clinical Research - Flourish ResearchWalnut Creek, California
- Clinical Site Partners, LLC DBA Flourish ResearchWinter Park, Florida
- Flourish Research - San Antonio Medical TrialsSan Antonio, Texas