RecruitingPhase 2

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

United States120 participantsStarted 2026-03-16

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. History of Type 1 or Type 2 diabetes
✕. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol
✕. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period
✕. 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

What they're measuring

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 30 weeks

Severity of TEAEs

Timeframe: Up to approximately 30 weeks

Maximum plasma Concentration (Cmax)

Timeframe: At week 15 and week 24

Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)

Timeframe: At week 15 and week 24

Trial details

NCT IDNCT07431086

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-23

Contact for this trial

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

View on ClinicalTrials.gov More Overweight or Obesity trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. History of Type 1 or Type 2 diabetes
✕. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol
✕. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period
✕. 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

What they're measuring

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 30 weeks

Severity of TEAEs

Timeframe: Up to approximately 30 weeks

Maximum plasma Concentration (Cmax)

Timeframe: At week 15 and week 24

Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)

Timeframe: At week 15 and week 24