Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Recruiting · NCT07685808 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
- Key
Exclusion criteria
- Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
- Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol
- Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol
- History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Where it is running
5 locations listed across 3 US states.
- Diablo Clinical Research - Flourish Research - Walnut Creek, California, United States
- K2 Medical Research Maitland LLC, Main Office - Maitland, Florida, United States
- Charter Research LLC - The Villages - The Villages, Florida, United States
- Clinical Site Partners, LLC DBA Flourish Research - Winter Park, Florida, United States
- AMR Clinical - Lexington - Lexington, Kentucky, United States