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RECRUITING
NCT07284979
PHASE3

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

Sponsor: Kailera

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-12-30

Completion Date

2028-04-17

Last Updated

2026-03-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

KAI-9531

SC Injection

DRUG

Semaglutide

SC Injection

DRUG

Placebo

SC Injection

Locations (25)

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

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