Current partner codePEPTIDESDE
NCT07284875·Phase 3·INTERVENTIONAL

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Status

Recruiting

Phase

Phase 3

Enrollment

2,340

Locations

88

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Ribupatide

SC Injection

DRUG

Placebo

SC Injection

Timeline

From registration to results.

  1. First posted

    Dec 16, 2025

  2. Study start

    Dec 18, 2025

  3. Primary completion

    Feb 2028

  4. Study completion

    Mar 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2026

Outcomes

What the study measures.

Primary outcomes

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame · Baseline, Week 76

Secondary outcomes

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

Who can take part.

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

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

88 registered sites.

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

Results and literature.

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

Primary links

Continue at the source.

Related trials

More studies on Glucagon.

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.