Phase 3 Study Comparing Weekly Ribupatide Injections with Semaglutide and Placebo for Adults with Obesity Without Diabetes

What this Trial Is About

Researchers are evaluating the effectiveness and safety of ribupatide KAI-9531 given as a once-weekly subcutaneous injection compared to semaglutide and placebo for people living with obesity who do not have diabetes. This Phase 3, randomized, partially-blinded study aims to show that ribupatide is superior in reducing body weight. Participants included have a body mass index BMI of 35 kgm or higher and a history of unsuccessful weight loss attempts through diet and exercise in the past 6 months. Participants will be randomly assigned to one of four groups two different doses of ribupatide once weekly, semaglutide once weekly, or a placebo injection once weekly. The study treatment is administered by subcutaneous injection, and the treatment period lasts for 76 weeks. The study compares the percentage change in body weight among these groups and also monitors several other health measures related to weight, metabolism, quality of life, and safety. During the study, participants will have regular visits for assessments including body weight, waist circumference, blood pressure, cholesterol levels, and questionnaires about eating behaviors and quality of life. Researchers will also monitor for any adverse events and test for antibodies against the study drugs throughout the 80-week period. The total participation duration may extend up to 80 weeks, including safety follow-up after the treatment period ends.

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes