DRUG
Ribupatide
SC Injection
Status
Recruiting
Phase
Phase 3
Enrollment
1,200
Locations
53
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 semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Interventions
DRUG
SC Injection
DRUG
SC Injection
DRUG
SC Injection
Timeline
First posted
Dec 16, 2025
Study start
Dec 30, 2025
Primary completion
Mar 2028
Study completion
Apr 2028
Results posted
Not reported
Registry updated
Jul 22, 2026
Outcomes
Percent Change From Baseline in Body Weight at Week 76
Time frame · Baseline, Week 76
Percentage of Participants with ≥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 ≥5% Reduction in 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
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame · Baseline, Week 76
Eligibility
Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (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 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, and phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within the 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, glucagon-like peptide-1 receptor (GLP-1R) 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
Australia · Bulgaria · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Kailera Clinical Site
Glendale, Arizona, United States
Kailera Clinical Site
Phoenix, Arizona, United States
Kailera Clinical Site
Little Rock, Arkansas, United States
Kailera Clinical Site
Northridge, California, United States
Kailera Clinical Site
Oceanside, California, United States
Kailera Clinical Site
Hamden, Connecticut, United States
Kailera Clinical Site
Stamford, Connecticut, United States
Kailera Clinical Site
Orange City, Florida, United States
Kailera Clinical Site
Albany, Georgia, United States
Kailera Clinical Site
Chicago, Illinois, United States
Kailera Clinical Site
Skokie, Illinois, United States
Kailera Clinical Site
Newton, Kansas, United States
Kailera Clinical Site
Shreveport, Louisiana, United States
Kailera Clinical Site
Farmington Hills, Michigan, United States
Kailera Clinical Site
Missoula, Montana, United States
Kailera Clinical Site
Las Vegas, Nevada, United States
Kailera Clinical Site
Albany, New York, United States
Kailera Clinical Site
Morehead City, North Carolina, United States
Kailera Clinical Site
Morrisville, North Carolina, United States
Kailera Clinical Site
Norman, Oklahoma, United States
Kailera Clinical Site
East Greenwich, Rhode Island, United States
Kailera Clinical Site
North Charleston, South Carolina, United States
Kailera Clinical Site
Spartanburg, South Carolina, United States
Kailera Clinical Site
Brownsville, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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