A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes

Condition studied

Obesity

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change in body weight (kg) from baseline at Week 76

Endpoint detail

controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg), controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score, not controlled for Type I error from baseline at Week 76: • Percentage of participants with ≥30% reduction in body weight (kg) • Change in BMI (kg/m2) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score, not controlled for Type I error Number ofTEAEs, not controlled for Type I error ADA NAb, not controlled for Type I error Concentrations of KAI-9531