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RECRUITING
NCT07497880
PHASE2

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

Sponsor: Kailera

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.

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

Interventions

DRUG

KAI-7535

Oral tablets

DRUG

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