Current partner codePEPTIDESDE
NCT07284901·Phase 3·INTERVENTIONAL

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Status

Recruiting

Phase

Phase 3

Enrollment

1,156

Locations

116

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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

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

    Jan 12, 2026

  3. Primary completion

    Mar 27, 2028

  4. Study completion

    Apr 24, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 15, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

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

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

116 registered sites.

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

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.