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

RECRUITINGPhase 2Sponsored by Regeneron Pharmaceuticals
Actively Recruiting
PhasePhase 2
SponsorRegeneron Pharmaceuticals
Started2026-07-28
Est. completion2028-01-21
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

DiabetesOverweight or Obesity

Interventions1

Locations5 sites

California

1 site
Diablo Clinical Research - Flourish Research
Walnut Creek, California, 94598

Florida

3 sites
K2 Medical Research Maitland LLC, Main Office
Maitland, Florida, 32751
Charter Research LLC - The Villages
The Villages, Florida, 32162
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, 32789

Kentucky

1 site
AMR Clinical - Lexington
Lexington, Kentucky, 40509

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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