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NCT07284901PHASE3Recruiting

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Kailera

Start Date

1/12/2026

Completion Date

4/24/2028

Summary

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM). * Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive. * BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. * History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. * History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. * 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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

Obesity With DiabetesOverweight With Diabetes

Locations

Kailera Clinical Site

Cullman, Alabama 35055

United States

Kailera Clinical Site

Phoenix, Arizona 85012

United States

Kailera Clinical Site

Sun City, Arizona 85351

United States

Kailera Clinical Site

Little Rock, Arkansas 72205

United States

Kailera Clinical Site

Escondido, California 92025

United States

Kailera Clinical Site

Montclair, California 91763

United States

Kailera Clinical Site

Northridge, California 91325

United States

Kailera Clinical Site

Oceanside, California 92058

United States

Kailera Clinical Site

Toluca Lake, California 91602

United States

Kailera Clinical Site

Stamford, Connecticut 06905

United States

Kailera Clinical Site

Jupiter, Florida 33458

United States

Kailera Clinical Site

Miami, Florida 33135

United States

Kailera Clinical Site

Orange City, Florida 32763

United States

Kailera Clinical Site

Orlando, Florida 32801

United States

Kailera Clinical Site

Orlando, Florida 32803

United States

Kailera Clinical Site

The Villages, Florida 32162

United States

Kailera Clinical Site

Lilburn, Georgia 30047

United States

Kailera Clinical Site

Skokie, Illinois 60077

United States

Kailera Clinical Site

Springfield, Illinois 62702

United States

Kailera Clinical Site

Newton, Kansas 67114

United States

Kailera Clinical Site

Shreveport, Louisiana 71105

United States

Kailera Clinical Site

Columbia, Maryland 21045

United States

Kailera Clinical Site

Farmington Hills, Michigan 48334

United States

Kailera Clinical Site

Missoula, Montana 59804

United States

Kailera Clinical Site

Lincoln, Nebraska 68516

United States

Kailera Clinical Site

Las Vegas, Nevada 89148

United States

Kailera Clinical Site

Albany, New York 12203

United States

Kailera Clinical Site

Laurelton, New York 11413

United States

Kailera Clinical Site

Greensboro, North Carolina 27405

United States

Kailera Clinical Site

Morehead City, North Carolina 28557

United States

Kailera Clinical Site

Chickasha, Oklahoma 73018

United States

Kailera Clinical Site

Spartanburg, South Carolina 29303

United States

Kailera Clinical Site

Chattanooga, Tennessee 37405

United States

Kailera Clinical Site

Amarillo, Texas 79124

United States

Kailera Clinical Site

Brownsville, Texas 78526

United States

Kailera Clinical Site

DeSoto, Texas 75115

United States

Kailera Clinical Site

Tomball, Texas 77375

United States

Kailera Clinical Site

Pleasant View, Utah 84404

United States

Kailera Clinical Site

Salt Lake City, Utah 84117

United States

Kailera Clinical Site

Manassas, Virginia 20110

United States

Kailera Clinical Site

Richmond, Virginia 23236

United States

Kailera Clinical Site

Ciudad Autonoma de Buenos Aires, Buenos Aires 1120

Argentina

Kailera Clinical Site

Mar del Plata, Buenos Aires 7600

Argentina

Kailera Clinical Site

San Nicolás de los Arroyos, Buenos Aires 2900

Argentina

Kailera Clinical Site

Zárate, Buenos Aires 2800

Argentina

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D. 1060

Argentina

Kailera Clinical Site

Godoy Cruz, Mendoza Province 5501

Argentina

Kailera Clinical Site

Rosario, Sante Fe 2000

Argentina

Kailera Clinical Site

CABA, 1061

Argentina

Kailera Clinical Site

Córdoba, 5002

Argentina

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

Leichhardt, New South Wales 2040

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

Herston, Queensland 4006

Australia

Kailera Clinical Site

Morayfield, Queensland 4506

Australia

Kailera Clinical Site

Camberwell, Victoria 3124

Australia

Kailera Clinical Site

Melbourne, Victoria 3025

Australia

Kailera Clinical Site

South Brisbane, 4101

Australia

Kailera Clinical Site

Kyustendil, Kyustendil Province 2500

Bulgaria

Kailera Clinical Site

Pleven, Pleven Province 5800

Bulgaria

Kailera Clinical Site

Plovdiv, Plovdiv Province 4020

Bulgaria

Kailera Clinical Site

Rousse, Ruse Province 7013

Bulgaria

Kailera Clinical Site

Sofia, Sofia 1606

Bulgaria

Kailera Clinical Site

Sofia, Sofia 1618

Bulgaria

Kailera Clinical Site

Stara Zagora, Stara Zagora Province 6000

Bulgaria

Kailera Clinical Site

Varna, Varna Province 9000

Bulgaria

Kailera Clinical Site

Montana, 3400

Bulgaria

Kailera Clinical Site

Brandýs nad Labem, Central Bohemia 25001

Czechia

Kailera Clinical Site

Náchod, Hradec Králové Region 54701

Czechia

Kailera Clinical Site

Trutnov, Hradec Králové Region 54101

Czechia

Kailera Clinical Site

Brno, South Moravian 60200

Czechia

Kailera Clinical Site

Holešov, Zlín 76901

Czechia

Kailera Clinical Site

Hodonín, 69501

Czechia

Kailera Clinical Site

Pardubice, 53002

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

Oldenburg in Holstein, Schleswig-Holstein 23758

Germany

Kailera Clinical Site

Schwerin, 19055

Germany

Kailera Clinical Site

Grafton, Auckland 1010

New Zealand

Kailera Clinical Site

New Lynn, Auckland 0610

New Zealand

Kailera Clinical Site

Silverdale, Auckland 0932

New Zealand

Kailera Clinical Site

Takapuna, Auckland 0622

New Zealand

Kailera Clinical Site

Nawton, Hamilton 3200

New Zealand

Kailera Clinical Site

Auckland, 1023

New Zealand

Kailera Clinical Site

Hastings, 4120

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 30-033

Poland

Kailera Clinical Site

Siedlce, Masovian Voivodeship 08-110

Poland

Kailera Clinical Site

Warsaw, Masovian Voivodeship 00-872

Poland

Kailera Clinical Site

Gdynia, Pomeranian Voivodeship 81-338

Poland

Kailera Clinical Site

Chorzów, Silesian Voivodeship 41-500

Poland

Kailera Clinical Site

Gdynia, 81-338

Poland

Kailera Clinical Site

Krakow, 30-363

Poland

Kailera Clinical Site

Warsaw, 02-677

Poland

Kailera Clinical Site

Skierniewice, Łódź Voivodeship 96-100

Poland

Kailera Clinical Site

Kielce, Świętokrzyskie Voivodeship 25-338

Poland

Kailera Clinical Site

San Juan, 00907

Puerto Rico

Kailera Clinical Site

Ferrol, A Coruna 15402

Spain

Kailera Clinical Site

Villamartín, Cadiz 11650

Spain

Kailera Clinical Site

Madrid, 28003

Spain

Kailera Clinical Site

Valencia, 46014

Spain

Kailera Clinical Site

Truro, Cornwall TR13LJ

United Kingdom

Kailera Clinical Site

Hull, East Yorkshire HU32JZ

United Kingdom

Kailera Clinical Site

London, Greater London EC1M6BQ

United Kingdom

Kailera Clinical Site

Leicester, Leicestershire LE54PW

United Kingdom

Kailera Clinical Site

Nottingham, Nottinghamshire NG72QW

United Kingdom

Kailera Clinical Site

Yate, South Gloucestershire BS374AX

United Kingdom

Kailera Clinical Site

Bradford, West Yorkshire BD96RJ

United Kingdom

Kailera Clinical Site

Manchester, M139WL

United Kingdom