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Clinical Trials in the USA / NCT07685808
Recruiting Phase 2

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

NCT07685808 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2026-07-28
Last updated
2026-10-26

Condition(s) studied

Overweight or Obesity

Investigational drug(s) / intervention(s)

Olatorepatide →Placebo

Olatorepatide: Administered per the protocol

Placebo: Administered per the protocol

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Up to approximately 60 weeks
  • Severity of TEAEs — Up to approximately 60 weeks
  • Percent change in body weight — From baseline to week 52

Trial sites (21)

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

More Regeneron Pharmaceuticals trials in the USA

A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body Recruiting
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition Recruiting
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma Active, not recruiting
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Recruiting
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension Recruiting

Other trials for the same condition

A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA) Active, not recruiting
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight Recruiting
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 Active, not recruiting
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities Active, not recruiting
Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07685808 on ClinicalTrials.gov ↗ ← All trials in the USA