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NCT07284979PHASE3Recruiting

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

Kailera

Start Date

12/30/2025

Completion Date

4/1/2028

Summary

The primary objective of this study is to demonstrate that ribupatide (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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (kg/m\^2). * History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus. * Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening. * Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer. * Uncontrolled hypertension or unstable cardiovascular disease. * History of chronic or acute pancreatitis. * Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Interventions

DRUG

Ribupatide

DRUG

Semaglutide

DRUG

Placebo

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Conditions

Obesity

Locations

Kailera Clinical Site

Glendale, Arizona 85308

United States

Kailera Clinical Site

Phoenix, Arizona 85012

United States

Kailera Clinical Site

Little Rock, Arkansas 72205

United States

Kailera Clinical Site

Northridge, California 91325

United States

Kailera Clinical Site

Oceanside, California 92058

United States

Kailera Clinical Site

Hamden, Connecticut 06517

United States

Kailera Clinical Site

Stamford, Connecticut 06905

United States

Kailera Clinical Site

Orange City, Florida 32763

United States

Kailera Clinical Site

Albany, Georgia 31707

United States

Kailera Clinical Site

Chicago, Illinois 60640

United States

Kailera Clinical Site

Skokie, Illinois 60077

United States

Kailera Clinical Site

Newton, Kansas 67114

United States

Kailera Clinical Site

Shreveport, Louisiana 71105

United States

Kailera Clinical Site

Farmington Hills, Michigan 48334

United States

Kailera Clinical Site

Missoula, Montana 59804

United States

Kailera Clinical Site

Las Vegas, Nevada 89148

United States

Kailera Clinical Site

Albany, New York 12203

United States

Kailera Clinical Site

Morehead City, North Carolina 28557

United States

Kailera Clinical Site

Morrisville, North Carolina 27560

United States

Kailera Clinical Site

Norman, Oklahoma 73069

United States

Kailera Clinical Site

East Greenwich, Rhode Island 02818

United States

Kailera Clinical Site

North Charleston, South Carolina 29405

United States

Kailera Clinical Site

Spartanburg, South Carolina 29303

United States

Kailera Clinical Site

Brownsville, Texas 78526

United States

Kailera Clinical Site

San Antonio, Texas 78229

United States

Kailera Clinical Site

Manassas, Virginia 20110

United States

Kailera Clinical Site

Richmond, Virginia 23236

United States

Kailera Clinical Site

Bruce, Australian Capital Territory 2617

Australia

Kailera Clinical Site

Blacktown, New South Wales 2148

Australia

Kailera Clinical Site

Kanwal, New South Wales 2259

Australia

Kailera Clinical Site

Herston, Queensland 4006

Australia

Kailera Clinical Site

Morayfield, Queensland 4506

Australia

Kailera Clinical Site

South Brisbane, Queensland 4101

Australia

Kailera Clinical Site

Camberwell, Victoria 3124

Australia

Kailera Clinical Site

Pleven, Pleven Province 5800

Bulgaria

Kailera Clinical Site

Plovdiv, Plovdiv Province 4000

Bulgaria

Kailera Clinical Site

Sofia, Sofia 1606

Bulgaria

Kailera Clinical Site

Sofia, Sofia 1618

Bulgaria

Kailera Clinical Site

Montana, 3400

Bulgaria

Kailera Clinical Site

Sofia, 1606

Bulgaria

Kailera Clinical Site

Sofia, 1616

Bulgaria

Kailera Clinical Site

Krakow, Lesser Poland Voivodeship 30-033

Poland

Kailera Clinical Site

Wroclaw, Lower Silesian Voivodeship 51-162

Poland

Kailera Clinical Site

Warsaw, Masovian Voivodeship 01-696

Poland

Kailera Clinical Site

Gdynia, Pomeranian Voivodeship 81-384

Poland

Kailera Clinical Site

Chorzów, Silesian Voivodeship 41-500

Poland

Kailera Clinical Site

Gdynia, 81-338

Poland

Kailera Clinical Site

Wroclaw, 51-162

Poland

Kailera Clinical Site

Kielce, Świętokrzyskie Voivodeship 25-338

Poland

Kailera Clinical Site

Exeter, Devon EX25DW

United Kingdom

Kailera Clinical Site

London, Greater London SW1P2PF

United Kingdom

Kailera Clinical Site

Leicester, Leicestershire LE54PW

United Kingdom

Kailera Clinical Site

Rotherham, South Yorkshire S651DA

United Kingdom