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
A phase 3 trial is testing KAI-9531, a once-weekly subcutaneous injection, versus semaglutide and placebo for weight loss in 1,200 people with obesity without diabetes. The 76-week randomized, partially-blinded study targets completion in March 2028 with percent body weight change as the primary endpoint. Kailera is positioning KAI-9531 as a direct competitor to Wegovy in the crowded obesity market, attempting to differentiate through superior weight loss efficacy. This represents another entrant challenging Novo Nordisk's established position in obesity treatment.