Testing the Safety and Effectiveness of Oral KAI-7535 in Adults With Obesity or Overweight and Weight-Related Conditions

What this Trial Is About

Researchers are evaluating the effectiveness of oral KAI-7535 taken once daily compared to a placebo in adults living with obesity or overweight who have at least one weight-related health condition, excluding those with diabetes mellitus. The study also examines how well KAI-7535 works in participants with type 2 diabetes mellitus. Safety, tolerability, and other weight-related results will be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a placebo once a day. The study includes multiple dosing schedules of KAI-7535 to evaluate its effects. The trial follows a parallel design with a quadruple masking method to ensure unbiased results. The treatment period lasts up to 44 weeks. Throughout the study, participants will have their body weight and body mass index measured at the start and at week 44. Researchers will track the percentage change in body weight and the number of participants achieving weight loss of 5% or 10%. Safety and tolerability will also be monitored. The entire participation period can last over 44 weeks, including screening and follow-up assessments.

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity