RecruitingPhase 2NCT07497880

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

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


Sponsor

Kailera

Enrollment

320 participants

Start Date

Apr 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KAI-7535 and a drug called Placebo for people with obesity and overweight. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKAI-7535

Oral tablets

DRUGPlacebo

Oral tablets


Locations(23)

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

Jacksonville, Florida, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Pembroke Pines, 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

Spartanburg, South Carolina, 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

Kailera Clinical Site

San Antonio, Texas, United States

Kailera Clinical Site

Sugar Land, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07497880


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