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

RecruitingPhase 2Ages 18 Years - anyAllRegeneron Pharmaceuticals
NCT07685808 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Olatorepatide
  • Placebo
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Where

21 sites
AMR Clinical - Mobile
Mobile, United States
Diablo Clinical Research - Flourish Research
Walnut Creek, United States
Chase Medical Research
Waterbury, United States
Alliance for Multispecialty Research (AMR) Clinical Miami
Doral, United States
AMR Clinical - Fort Myers
Fort Myers, United States
AGA Clinical Trials
Hialeah, United States
Flourish Research, Nature Coast Clinical Research
Inverness, United States
Flourish Research, Jacksonville Center for Clinical Research
Jacksonville, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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