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NCT07284875PHASE3Recruiting

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Kailera

Start Date

12/18/2025

Completion Date

3/1/2028

Summary

The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following: 1. hypertension, 2. dyslipidemia, 3. obstructive sleep apnea, or 4. cardiovascular (CV) disease. * History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months. 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, or phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within 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, GLP-1 receptor 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

Placebo

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Conditions

ObesityOverweight

Locations

Kailera Clinical Site

Anniston, Alabama 36207

United States

Kailera Clinical Site

Birmingham, Alabama 35294

United States

Kailera Clinical Site

Cullman, Alabama 35055

United States

Kailera Clinical Site

Sun City, Arizona 85351

United States

Kailera Clinical Site

Escondido, California 92025

United States

Kailera Clinical Site

Toluca Lake, California 91602

United States

Kailera Clinical Site

Aurora, Colorado 80012

United States

Kailera Clinical Site

Bridgeport, Connecticut 06606

United States

Kailera Clinical Site

Jupiter, Florida 33458

United States

Kailera Clinical Site

Lilburn, Georgia 30047

United States

Kailera Clinical Site

Springfield, Illinois 62072

United States

Kailera Clinical Site

Columbia, Maryland 21045

United States

Kailera Clinical Site

Las Vegas, Nevada 89119

United States

Kailera Clinical Site

Rochester, New York 14609

United States

Kailera Clinical Site

Morehead City, North Carolina 28557

United States

Kailera Clinical Site

Chickasha, Oklahoma 73018

United States

Kailera Clinical Site

Mauldin, South Carolina 29662

United States

Kailera Clinical Site

Chattanooga, Tennessee 37405

United States

Kailera Clinical Site

Amarillo, Texas 79124

United States

Kailera Clinical Site

Bellaire, Texas 77401

United States

Kailera Clinical Site

DeSoto, Texas 75115

United States

Kailera Clinical Site

Tomball, Texas 77375

United States

Kailera Clinical Site

Salt Lake City, Utah 84124

United States

Kailera Clinical Site

Danville, Virginia 24541

United States

Kailera Clinical Site

San Nicolás de los Arroyos, Buenos Aires 2900

Argentina

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D. 1056

Argentina

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D. 1060

Argentina

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D. 1120

Argentina

Kailera Clinical Site

Godoy Cruz, Mendoza Province 5501

Argentina

Kailera Clinical Site

Rosario, Santa Fe Province 2000

Argentina

Kailera Clinical Site

CABA, 1061

Argentina

Kailera Clinical Site

Córdoba, 5000

Argentina

Kailera Clinical Site

Silverdale, Auckland 0932

Australia

Kailera Clinical Site

Charlestown, New South Wales 2290

Australia

Kailera Clinical Site

Sydney, New South Wales 2019

Australia

Kailera Clinical Site

Sydney, New South Wales 2100

Australia

Kailera Clinical Site

Sydney, New South Wales 2228

Australia

Kailera Clinical Site

Wollongong, New South Wales 2500

Australia

Kailera Clinical Site

Sippy Downs, Queensland 4556

Australia

Kailera Clinical Site

Norwood, South Australia 5067

Australia

Kailera Clinical Site

Heidelberg Heights, Victoria 3081

Australia

Kailera Clinical Site

Melbourne, Victoria 3025

Australia

Kailera Clinical Site

Kyustendil, Kyustendil Province 2500

Bulgaria

Kailera Clinical Site

Pazardzhik, 4400

Bulgaria

Kailera Clinical Site

Plovdiv, 4000

Bulgaria

Kailera Clinical Site

Plovdiv, 4020

Bulgaria

Kailera Clinical Site

Sofia, 1431

Bulgaria

Kailera Clinical Site

Sofia, 1510

Bulgaria

Kailera Clinical Site

Varna, 9020

Bulgaria

Kailera Clinical Site

Yambol, 8600

Bulgaria

Kailera Clinical Site

Brandýs nad Labem, Central Bohemia 25001

Czechia

Kailera Clinical Site

Náchod, Hradec Králové Region 54701

Czechia

Kailera Clinical Site

Brno, South Moravian 61500

Czechia

Kailera Clinical Site

Hodonín, 69501

Czechia

Kailera Clinical Site

Uherské Hradiště, 68601

Czechia

Kailera Clinical Site

Falkensee, Brandenburg 14612

Germany

Kailera Clinical Site

Cologne, North Rhine-Westphalia 51069

Germany

Kailera Clinical Site

Essen, North Rhine-Westphalia 45355

Germany

Kailera Clinical Site

Dresden, Saxony 01069

Germany

Kailera Clinical Site

Leipzig, Saxony 04107

Germany

Kailera Clinical Site

Oldenburg in Holstein, Schleswig-Holstein 23758

Germany

Kailera Clinical Site

Hamburg, 22415

Germany

Kailera Clinical Site

Hamburg, 22607

Germany

Kailera Clinical Site

Schwerin, 19055

Germany

Kailera Clinical Site

Grafton, Auckland 1010

New Zealand

Kailera Clinical Site

Hamilton, Waikato Region 3200

New Zealand

Kailera Clinical Site

Auckland, 0610

New Zealand

Kailera Clinical Site

Nelson, 7011

New Zealand

Kailera Clinical Site

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

Kailera Clinical Site

Krakow, Lesser Poland Voivodeship 30-363

Poland

Kailera Clinical Site

Siedlce, Masovian Voivodeship 08-110

Poland

Kailera Clinical Site

Warsaw, Masovian Voivodeship 00-872

Poland

Kailera Clinical Site

Skierniewice, 96-100

Poland

Kailera Clinical Site

Zamość, 22-400

Poland

Kailera Clinical Site

Ferrol, A Coruna 15402

Spain

Kailera Clinical Site

Villamartín, Cadiz 11650

Spain

Kailera Clinical Site

Castilleja de la Cuesta, Sevilla 41950

Spain

Kailera Clinical Site

Barcelona, 08023

Spain

Kailera Clinical Site

Madrid, 28003

Spain

Kailera Clinical Site

Valencia, 46014

Spain

Kailera Clinical Site

Soham, Cambridgeshire NG72QW

United Kingdom

Kailera Clinical Site

Torpoint, Cornwall PL112TB

United Kingdom

Kailera Clinical Site

Hull, East Yorkshire HU32JZ

United Kingdom

Kailera Clinical Site

Leicester, Leicestershire LE54PW

United Kingdom

Kailera Clinical Site

Nottingham, Nottinghamshire NG72QW

United Kingdom

Kailera Clinical Site

Hounslow, YW47NJ

United Kingdom

Kailera Clinical Site

London, EC1M6BQ

United Kingdom

Kailera Clinical Site

Manchester, M139WL

United Kingdom