Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and 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 and Diabetes
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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)
What is being tested
- Ribupatide (drug)
- Placebo (drug)
Sponsor: Kailera · Participants: 1,156 · Started: Jan 12, 2026
Contact the study team
- Kailera Therapeutics, Inc. · Phone: 1-781-317-0291
Official record on ClinicalTrials.gov — NCT07284901
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.