RecruitingPhase 2NCT07431086

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US

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

Sponsor

Regeneron Pharmaceuticals

Enrollment

120 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Overweight or Obesity

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 your body makes antibodies to the study drug, as this may cause the study drug to not work as well

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

Body mass index ≥27.0 kg/m\^2 to \<45.0 kg/m\^2 at screening
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

Exclusion Criteria5

History of Type 1 or Type 2 diabetes
Change in body weight \>5 kg within approximately 3 months before screening
History of gastrointestinal (GI) surgery or procedures for weight management including bariatric surgery or planned bariatric surgery (includes removal or reversal, etc); presence of serious GI disorders (eg, active peptic ulcer, inflammatory bowel disease) and/or history of clinically significant gastric emptying abnormality or on chronic medication that alters GI motility
Past medical history of moderate to severe depression or history of suicidal behavior, or past medical history of serious psychiatric disorder as described in the protocol
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

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