DRUG
Ribupatide
SC Injection
Status
Recruiting
Phase
Phase 3
Enrollment
1,156
Locations
116
Results
Not posted
Publications
0
Study 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)
Interventions
DRUG
SC Injection
DRUG
SC Injection
Timeline
First posted
Dec 16, 2025
Study start
Jan 12, 2026
Primary completion
Mar 27, 2028
Study completion
Apr 24, 2028
Results posted
Not reported
Registry updated
Jul 15, 2026
Outcomes
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame · Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time frame · Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame · Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time frame · Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time frame · Baseline, Week 76
Change From Baseline in Waist Circumference
Time frame · Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time frame · Baseline, Week 76
Percentage of Participants with HbA1c <7% and ≤6.5%
Time frame · Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time frame · Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time frame · Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame · Baseline, Week 76
Eligibility
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.
Study locations
Argentina · Australia · Bulgaria · Czechia · Germany · New Zealand · Poland · Puerto Rico · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
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
Jupiter, Florida, United States
Kailera Clinical Site
Miami, 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
Lilburn, 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
Columbia, Maryland, United States
Kailera Clinical Site
Farmington Hills, Michigan, United States
Kailera Clinical Site
Missoula, Montana, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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