Active, not recruitingPhase 2Interventional
What this study is about
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much the study drug is in the blood at different times * How well the study drug works * If the body makes antibodies to the study drug as this may cause the study drug to not work as well
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obesity
Full registry criteria
Key Inclusion Criteria: 1. Body mass index ≥27.0 kg/m\^2 to \<45.0 kg/m\^2 at screening 2. Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment Key Exclusion Criteria: 1. History of Type 1 or Type 2 diabetes 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, prior to randomization or planned during the study period 4. History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Treatments and study arms
Olatorepatide
Drug
Administered per the protocol
Placebo
Drug
Administered per the protocol
Primary outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)Up to approximately 30 weeks
Severity of TEAEsUp to approximately 30 weeks
Maximum plasma Concentration (Cmax)At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)At week 15 and week 24
Study locations
3 locations were listed when this page was built. The first 40 are shown.
Flourish Research - San Antonio Medical Trials🇺🇸 San Antonio, Texas, United States Diablo Clinical Research - Flourish Research🇺🇸 Walnut Creek, California, United States Clinical Site Partners, LLC DBA Flourish Research🇺🇸 Winter Park, Florida, United States 