RecruitingPhase 3NCT07284979

Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Sponsor

Kailera

Enrollment

1,200 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity

Summary

The primary objective of this study is to demonstrate that 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KAI-9531, a drug called Placebo, and others for people with obesity. The study is currently recruiting participants at 33 locations. People eligible for this study include aged 18 Years and older.

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-9531

SC Injection

DRUGSemaglutide

SC Injection

DRUGPlacebo

SC Injection

Locations(33)

Kailera Clinical Site

Glendale, Arizona, United States

Kailera Clinical Site

Phoenix, Arizona, United States

Kailera Clinical Site

Little Rock, Arkansas, United States

Kailera Clinical Site

Northridge, California, United States

Kailera Clinical Site

Oceanside, California, United States

Kailera Clinical Site

Hamden, Connecticut, United States

Kailera Clinical Site

Stamford, Connecticut, United States

Kailera Clinical Site

Orange City, Florida, United States

Kailera Clinical Site

Albany, Georgia, United States

Kailera Clinical Site

Chicago, Illinois, United States

Kailera Clinical Site

Skokie, Illinois, United States

Kailera Clinical Site

Newton, Kansas, United States

Kailera Clinical Site

Shreveport, Louisiana, United States

Kailera Clinical Site

Farmington Hills, Michigan, United States

Kailera Clinical Site

Missoula, Montana, United States

Kailera Clinical Site

Las Vegas, Nevada, United States

Kailera Clinical Site

Albany, New York, United States

Kailera Clinical Site

Morehead City, North Carolina, United States

Kailera Clinical Site

Norman, Oklahoma, United States

Kailera Clinical Site

East Greenwich, Rhode Island, United States

Kailera Clinical Site

North Charleston, South Carolina, United States

Kailera Clinical Site

Spartanburg, South Carolina, United States

Kailera Clinical Site

Brownsville, Texas, United States

Kailera Clinical Site

San Antonio, Texas, United States

Kailera Clinical Site

Manassas, Virginia, United States

Kailera Clinical Site

Richmond, Virginia, United States

Kailera Clinical Site

Bruce, Australian Capital Territory, Australia

Kailera Clinical Site

Blacktown, New South Wales, Australia

Kailera Clinical Site

Kanwal, New South Wales, Australia

Kailera Clinical Site

Herston, Queensland, Australia

Kailera Clinical Site

Morayfield, Queensland, Australia

Kailera Clinical Site

South Brisbane, Queensland, Australia

Kailera Clinical Site

Camberwell, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07284979

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