About this trial
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI ≥35 kilograms per square meter (kg/m²).
History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
Disqualifiers
Current diagnosis or history of diabetes mellitus.
Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.
Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
Trial design
Parallel
Treatments tested in this trial
Ribupatide
DrugSC Injection
Semaglutide
DrugSC Injection
Placebo
DrugSC Injection
Treatment groups
Trial outcomes
Primary outcomes
Percent Change From Baseline in Body Weight at Week 76
Secondary outcomes
Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Change From Baseline in Waist Circumference
Change From Baseline in Absolute Body Weight
Percentage of Participants with ≥5% Reduction in Body Weight