Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US
Registered Phase 2 interventional trial (active not recruiting). 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 diff
Registered clinical trial record on ClinicalTrials.gov (NCT07431086). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: active not recruiting. Study type: interventional. Phase: Phase 2. Sponsor: Regeneron Pharmaceuticals. Conditions: Overweight or Obesity. Interventions: Olatorepatide, Placebo. 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 Primary outcome measures: Occurrence of Treatment-Emergent Adverse Events (TEAEs); Severity of TEAEs; Maximum plasma Concentration (Cmax); Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h). Eligibility: 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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