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Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Sponsor: Kailera
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.
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-04-06
Completion Date
2027-07-07
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
KAI-7535
Oral tablets
Placebo
Oral tablets
Locations (18)
Kailera Clinical Site
Chandler, Arizona, United States
Kailera Clinical Site
Irvine, California, United States
Kailera Clinical Site
Lincoln, California, United States
Kailera Clinical Site
Northridge, California, United States
Kailera Clinical Site
Hamden, Connecticut, United States
Kailera Clinical Site
Jupiter, Florida, United States
Kailera Clinical Site
Decatur, Georgia, United States
Kailera Clinical Site
Skokie, Illinois, United States
Kailera Clinical Site
South Bend, Indiana, United States
Kailera Clinical Site
Kenner, Louisiana, United States
Kailera Clinical Site
Garden City, Michigan, United States
Kailera Clinical Site
Jefferson City, Missouri, United States
Kailera Clinical Site
Kansas City, Missouri, United States
Kailera Clinical Site
Knoxville, Tennessee, United States
Kailera Clinical Site
Austin, Texas, United States
Kailera Clinical Site
Brownsville, Texas, United States
Kailera Clinical Site
Farmers Branch, Texas, United States
Kailera Clinical Site
San Antonio, Texas, United States