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ACTIVE NOT RECRUITING

NCT07284901

PHASE3

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

Sponsor: Kailera

View on ClinicalTrials.gov

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)

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1270

Start Date

2026-01-12

Completion Date

2028-04-24

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Obesity With Diabetes Overweight With Diabetes

Interventions

DRUG

Ribupatide

SC Injection

DRUG

Placebo

SC Injection

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.

Locations (173)

Kailera Clinical Site

Cullman, Alabama, United States

Kailera Clinical Site

Phoenix, Arizona, United States

Kailera Clinical Site

Sun City, Arizona, United States

Kailera Clinical Site

Little Rock, Arkansas, United States

Kailera Clinical Site

Escondido, California, United States

Kailera Clinical Site

La Mesa, California, United States

Kailera Clinical Site

Montclair, California, United States

Kailera Clinical Site

Northridge, California, United States

Kailera Clinical Site

Oceanside, California, United States

Kailera Clinical Site

Toluca Lake, California, United States

Kailera Clinical Site

Stamford, Connecticut, United States

Kailera Clinical Site

Bradenton, Florida, United States

Kailera Clinical Site

Hollywood, Florida, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Miami, Florida, United States

Kailera Clinical Site

Miami Lakes, Florida, United States

Kailera Clinical Site

Orange City, Florida, United States

Kailera Clinical Site

Orlando, Florida, United States

Kailera Clinical Site

Orlando, Florida, United States

Kailera Clinical Site

The Villages, Florida, United States

Kailera Clinical Site

Decatur, Georgia, United States

Kailera Clinical Site

Lilburn, Georgia, United States

Kailera Clinical Site

Marietta, Georgia, United States

Kailera Clinical Site

Riverdale, Georgia, United States

Kailera Clinical Site

Skokie, Illinois, United States

Kailera Clinical Site

Springfield, Illinois, United States

Kailera Clinical Site

Newton, Kansas, United States

Kailera Clinical Site

Shreveport, Louisiana, United States

Kailera Clinical Site

Annapolis, Maryland, United States

Kailera Clinical Site

Columbia, Maryland, United States

Kailera Clinical Site

Boston, Massachusetts, United States

Kailera Clinical Site

Farmington Hills, Michigan, United States

Kailera Clinical Site

Missoula, Montana, United States

Kailera Clinical Site

Lincoln, Nebraska, United States

Kailera Clinical Site

Las Vegas, Nevada, United States

Kailera Clinical Site

Albany, New York, United States

Kailera Clinical Site

Laurelton, New York, United States

Kailera Clinical Site

New York, New York, United States

Kailera Clinical Site

Greensboro, North Carolina, United States

Kailera Clinical Site

Monroe, North Carolina, United States

Kailera Clinical Site #1

Morehead City, North Carolina, United States

Kailera Clinical Site #2

Morehead City, North Carolina, United States

Kailera Clinical Site

Morrisville, North Carolina, United States

Kailera Clinical Site

Cleveland, Ohio, United States

Kailera Clinical Site

Chickasha, Oklahoma, United States

Kailera Clinical Site

East Greenwich, Rhode Island, United States

Kailera Clinical Site

Spartanburg, South Carolina, United States

Kailera Clinical Site

Chattanooga, Tennessee, United States

Kailera Clinical Site

Memphis, Tennessee, United States

Kailera Clinical Site

Amarillo, Texas, United States

Kailera Clinical Site

Brownsville, Texas, United States

Kailera Clinical Site

DeSoto, Texas, United States

Kailera Clinical Site

El Paso, Texas, United States

Kailera Clinical Site

Farmers Branch, Texas, United States

Kailera Clinical Site

Kingwood, Texas, United States

Kailera Clinical Site

Plano, Texas, United States

Kailera Clinical Site

Tomball, Texas, United States

Kailera Clinical Site

Pleasant View, Utah, United States

Kailera Clinical Site

Salt Lake City, Utah, United States

Kailera Clinical Site

Manassas, Virginia, United States

Kailera Clinical Site

Richmond, Virginia, United States

Kailera Clinical Site

Seattle, Washington, United States

Kailera Clinical Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Kailera Clinical Site

La Plata, Buenos Aires, Argentina

Kailera Clinical Site

Mar del Plata, Buenos Aires, Argentina

Kailera Clinical Site

San Nicolás de los Arroyos, Buenos Aires, Argentina

Kailera Clinical Site

Zárate, Buenos Aires, Argentina

Kailera Clinical Site

Godoy Cruz, Mendoza Province, Argentina

Kailera Clinical Site #1

Rosario, Santa Fe Province, Argentina

Kailera Clinical Site #2

Rosario, Santa Fe Province, Argentina

Kailera Clinical Site #3

Rosario, Santa Fe Province, Argentina

Kailera Clinical Site #4

Rosario, Sante Fe, Argentina

Kailera Clinical Site #1

Buenos Aires, Argentina

Kailera Clinical Site #2

Buenos Aires, Argentina

Kailera Clinical Site

Buenos Aires, Argentina

Kailera Clinical Site

Buenos Aires, Argentina

Kailera Clinical Site

Buenos Aires, Argentina

Kailera Clinical Site

Córdoba, Argentina

Kailera Clinical Site

Córdoba, Argentina

Kailera Clinical Site

Bruce, Australian Capital Territory, Australia

Kailera Clinical Site

Blacktown, New South Wales, Australia

Kailera Clinical Site

Charlestown, New South Wales, Australia

Kailera Clinical Site

Kanwal, New South Wales, Australia

Kailera Clinical Site

Leichhardt, New South Wales, Australia

Kailera Clinical Site

Penrith, New South Wales, Australia

Kailera Clinical Site

Sydney, New South Wales, Australia

Kailera Clinical Site

Sydney, New South Wales, Australia

Kailera Clinical Site

Wollongong, New South Wales, Australia

Kailera Clinical Site

Herston, Queensland, Australia

Kailera Clinical Site

Morayfield, Queensland, Australia

Kailera Clinical Site

Camberwell, Victoria, Australia

Kailera Clinical Site

Melbourne, Victoria, Australia

Kailera Clinical Site

South Brisbane, Australia

Kailera Clinical Site

Kyustendil, Kyustendil Province, Bulgaria

Kailera Clinical Site

Pleven, Pleven Province, Bulgaria

Kailera Clinical Site

Plovdiv, Plovdiv Province, Bulgaria

Kailera Clinical Site

Rousse, Ruse Province, Bulgaria

Kailera Clinical Site

Sofia, Sofia, Bulgaria

Kailera Clinical Site

Sofia, Sofia, Bulgaria

Kailera Clinical Site

Sofia, Sofia, Bulgaria

And 73 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (173)