Skip to main content
Back to Trials
NCT07685808PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

7/28/2026

Completion Date

1/21/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Olatorepatide

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Overweight or Obesity

Locations

AMR Clinical - Mobile

Mobile, Alabama 36608

United States

Diablo Clinical Research - Flourish Research

Walnut Creek, California 94598

United States

Chase Medical Research

Waterbury, Connecticut 06708

United States

Alliance for Multispecialty Research (AMR) Clinical Miami

Doral, Florida 33172

United States

AMR Clinical - Fort Myers

Fort Myers, Florida 33912

United States

AGA Clinical Trials

Hialeah, Florida 33012

United States

Flourish Research, Nature Coast Clinical Research

Inverness, Florida 34452

United States

Flourish Research, Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

K2 Medical Research Maitland LLC, Main Office

Maitland, Florida 32751

United States

The IMA Group, IMA Clinical Research St. Petersburg

St. Petersburg, Florida 33704

United States

Charter Research LLC - The Villages

The Villages, Florida 32162

United States

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida 32789

United States

Charter Research LLC - Chicago

Chicago, Illinois 60618

United States

Flourish Research - Chicago

Chicago, Illinois 60625

United States

AMR Clinical - Chicago Oak Brook

Oak Brook, Illinois 60523

United States

AMR Clinical - Wichita

Wichita, Kansas 67207

United States

AMR Clinical - Lexington

Lexington, Kentucky 40509

United States

Velocity Clinical Research - Omaha

Omaha, Nebraska 68134

United States

NYC Research Inc

New York, New York 10016

United States

Rochester Clinical Research

Rochester, New York 14609

United States

Tribe Clinical Research

Greenville, South Carolina 29607

United States