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RECRUITING Phase 2 ClinicalTrials.gov

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07685808

Registry updated: 2026-10-13
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Description

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much study drug is in the blood at different times * How well the study drug works * What effects the study drug may have on the body at different dosing schedules * If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Interventions

  • Olatorepatide (Drug)
    Administered per the protocol
  • Placebo (Drug)
    Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Body Mass Index (BMI) ≥30.0 kg/m\^2 to \<45.0 kg/m\^2 at screening OR 2. BMI ≥27.0 kg/m\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol Key Exclusion Criteria: 1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening 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 as described in the protocol 4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones 5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Conditions

Overweight or Obesity

Locations

  • AMR Clinical - Mobile — Mobile, Alabama, United States
  • Diablo Clinical Research - Flourish Research — Walnut Creek, California, United States
  • Chase Medical Research — Waterbury, Connecticut, United States
  • Alliance for Multispecialty Research (AMR) Clinical Miami — Doral, Florida, United States
  • AMR Clinical - Fort Myers — Fort Myers, Florida, United States
  • AGA Clinical Trials — Hialeah, Florida, United States
  • Flourish Research, Nature Coast Clinical Research — Inverness, Florida, United States
  • Flourish Research, Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
  • K2 Medical Research Maitland LLC, Main Office — Maitland, Florida, United States
  • The IMA Group, IMA Clinical Research St. Petersburg — St. Petersburg, Florida, United States
  • Charter Research LLC - The Villages — The Villages, Florida, United States
  • Clinical Site Partners, LLC DBA Flourish Research — Winter Park, Florida, United States
  • Charter Research LLC - Chicago — Chicago, Illinois, United States
  • Flourish Research - Chicago — Chicago, Illinois, United States
  • AMR Clinical - Chicago Oak Brook — Oak Brook, Illinois, United States
  • AMR Clinical - Wichita — Wichita, Kansas, United States
  • AMR Clinical - Lexington — Lexington, Kentucky, United States
  • Velocity Clinical Research - Omaha — Omaha, Nebraska, United States
  • NYC Research Inc — New York, New York, United States
  • Rochester Clinical Research — Rochester, New York, United States
  • Tribe Clinical Research — Greenville, South Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record