DRUG
Ribupatide
SC Injection
Status
Recruiting
Phase
Phase 3
Enrollment
2,340
Locations
88
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
SC Injection
DRUG
SC Injection
Timeline
First posted
Dec 16, 2025
Study start
Dec 18, 2025
Primary completion
Feb 2028
Study completion
Mar 2028
Results posted
Not reported
Registry updated
Jul 22, 2026
Outcomes
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame · Baseline, Week 76
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight 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
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
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame · Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame · Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Time frame · Baseline, Week 76
Eligibility
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.
Study locations
Argentina · Australia · Bulgaria · Czechia · Germany · New Zealand · Poland · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Kailera Clinical Site
Anniston, Alabama, United States
Kailera Clinical Site
Birmingham, Alabama, United States
Kailera Clinical Site
Cullman, Alabama, United States
Kailera Clinical Site
Sun City, Arizona, United States
Kailera Clinical Site
Escondido, California, United States
Kailera Clinical Site
Toluca Lake, California, United States
Kailera Clinical Site
Aurora, Colorado, United States
Kailera Clinical Site
Bridgeport, Connecticut, United States
Kailera Clinical Site
Jupiter, Florida, United States
Kailera Clinical Site
Lilburn, Georgia, United States
Kailera Clinical Site
Springfield, Illinois, United States
Kailera Clinical Site
Columbia, Maryland, United States
Kailera Clinical Site
Las Vegas, Nevada, United States
Kailera Clinical Site
Rochester, New York, United States
Kailera Clinical Site
Morehead City, North Carolina, United States
Kailera Clinical Site
Chickasha, Oklahoma, United States
Kailera Clinical Site
Mauldin, South Carolina, United States
Kailera Clinical Site
Chattanooga, Tennessee, United States
Kailera Clinical Site
Amarillo, Texas, United States
Kailera Clinical Site
Bellaire, Texas, United States
Kailera Clinical Site
DeSoto, Texas, United States
Kailera Clinical Site
Tomball, Texas, United States
Kailera Clinical Site
Salt Lake City, Utah, United States
Kailera Clinical Site
Danville, Virginia, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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