Olatorepatide in adults who are overweight or have obesity (without diabetes) test of safety and dosing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates different doses and dosing schedules of olatorepatide in adults with overweight or obesity but no diabetes. Participants are randomized to receive the study drug or placebo to assess safety, how the drug behaves in the body, and its effect on weight and related factors. The study also checks for antibody development against the drug and potential dose-related side effects. Key outcomes include dose-finding, tolerability, pharmacokinetics, and preliminary efficacy signals.

Why it matters

Who can join: the full rules

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

Where it's running

• AMR Clinical - Mobile
  Mobile, Alabama, United States Recruiting
• Diablo Clinical Research - Flourish Research
  Walnut Creek, California, United States Recruiting
• Chase Medical Research
  Waterbury, Connecticut, United States Recruiting
• Alliance for Multispecialty Research (AMR) Clinical Miami
  Doral, Florida, United States Recruiting
• AMR Clinical - Fort Myers
  Fort Myers, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.