Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
RecruitingPhase 3
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 With Weight-Related Comorbidities Who Do Not Have Diabetes
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Ribupatide (drug)
- Placebo (drug)
Sponsor: Kailera · Participants: 2,340 · Started: Dec 18, 2025
Contact the study team
- Kailera Therapeutics, Inc. · Phone: 781-317-0291
Official record on ClinicalTrials.gov — NCT07284875
Locations in the U.S.
| Alabama | Kailera Clinical Site, Anniston Kailera Clinical Site, Birmingham Kailera Clinical Site, Cullman |
| Arizona | Kailera Clinical Site, Sun City |
| California | Kailera Clinical Site, Escondido Kailera Clinical Site, Toluca Lake |
| Colorado | Kailera Clinical Site, Aurora |
| Connecticut | Kailera Clinical Site, Bridgeport |
| Florida | Kailera Clinical Site, Jupiter |
| Georgia | Kailera Clinical Site, Lilburn |
| Illinois | Kailera Clinical Site, Springfield |
| Maryland | Kailera Clinical Site, Columbia |
| Nevada | Kailera Clinical Site, Las Vegas |
| New York | Kailera Clinical Site, Rochester |
| North Carolina | Kailera Clinical Site, Morehead City |
| Oklahoma | Kailera Clinical Site, Chickasha |
| South Carolina | Kailera Clinical Site, Mauldin |
| Tennessee | Kailera Clinical Site, Chattanooga |
| Texas | Kailera Clinical Site, Amarillo Kailera Clinical Site, Bellaire Kailera Clinical Site, DeSoto Kailera Clinical Site, Tomball |
| Utah | Kailera Clinical Site, Salt Lake City |
| Virginia | Kailera Clinical Site, Danville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.