Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Protocol Amendment History 6 changes
notable Trial sites expanded: 33 -> 36 locations 2026-07-29
notable Trial sites expanded: 23 -> 32 locations 2026-07-16
notable Trial sites expanded: 19 -> 23 locations 2026-06-17
notable Trial sites expanded: 10 -> 18 locations 2026-05-29
notable Trial sites expanded: 2 -> 10 locations 2026-05-14
critical Recruitment opened 2026-04-28
Trial Details
NCT Number NCT07497880
Lead Sponsor Kailera
Conditions Obesity, Overweight
Enrollment 320 participants
Start Date 2026-04-06
Primary Completion 2027-07-07 (estimated)
Study Completion 2027-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-28