Current partner codePEPTIDESDE
NCT07284979·Phase 3·INTERVENTIONAL

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Status

Recruiting

Phase

Phase 3

Enrollment

1,200

Locations

53

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Ribupatide

SC Injection

DRUG

Semaglutide

SC Injection

DRUG

Placebo

SC Injection

Timeline

From registration to results.

  1. First posted

    Dec 16, 2025

  2. Study start

    Dec 30, 2025

  3. Primary completion

    Mar 2028

  4. Study completion

    Apr 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 76

Time frame · Baseline, Week 76

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

53 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.