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HomeTrials › NCT07685808

Obesity & weight · Phase 2 · Recruiting now

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

NCT07685808 · Sponsor: Regeneron Pharmaceuticals

What this trial means for you

This study is recruiting now at 5 US sites. It's studying Olatorepatide, Placebo for overweight or obesity.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo, diagnosis required
What you'd takeOlatorepatide, Placebo
Study length~18 months overall
Planned participants360
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

California

  • Diablo Clinical Research - Flourish Research, Walnut Creek · Recruiting now

Florida

  • K2 Medical Research Maitland LLC, Main Office, Maitland · Recruiting now
  • Charter Research LLC - The Villages, The Villages · Recruiting now
  • Clinical Site Partners, LLC DBA Flourish Research, Winter Park · Recruiting now

Kentucky

  • AMR Clinical - Lexington, Lexington · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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