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A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Body Mass Index (BMI) ≥30.0 kg/m\^2 to \<45.0 kg/m\^2 at screening OR

• 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

Locations
United States
California
Diablo Clinical Research - Flourish Research
RECRUITING
Walnut Creek
Florida
K2 Medical Research Maitland LLC, Main Office
RECRUITING
Maitland
Charter Research LLC - The Villages
RECRUITING
The Villages
Clinical Site Partners, LLC DBA Flourish Research
RECRUITING
Winter Park
Kentucky
AMR Clinical - Lexington
RECRUITING
Lexington
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-07-28
Estimated Completion Date: 2028-01-21
Participants
Target number of participants: 360
Treatments
Experimental: Olatorepatide arm 1
Experimental: Olatorepatide arm 2
Experimental: Olatorepatide arm 3
Experimental: Olatorepatide arm 4
Experimental: Olatorepatide arm 5
Active_comparator: Matching Placebo arm 6
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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