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Active, not recruiting Phase 3

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

NCT07284901 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Phase 3
Started
2026-01-12
Last updated
2026-10-06

Condition(s) studied

Obesity With DiabetesOverweight With Diabetes

Investigational drug(s) / intervention(s)

Ribupatide →Placebo

Ribupatide: SC Injection

Placebo: SC Injection

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 — Baseline, Week 76
  • Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 — Baseline, Week 76

Trial sites (173)

FacilityCityRegionStatus
Kailera Clinical Site Cullman Alabama
Kailera Clinical Site Phoenix Arizona
Kailera Clinical Site Sun City Arizona
Kailera Clinical Site Little Rock Arkansas
Kailera Clinical Site Escondido California
Kailera Clinical Site La Mesa California
Kailera Clinical Site Montclair California
Kailera Clinical Site Northridge California
Kailera Clinical Site Oceanside California
Kailera Clinical Site Toluca Lake California
Kailera Clinical Site Stamford Connecticut
Kailera Clinical Site Bradenton Florida
Kailera Clinical Site Hollywood Florida
Kailera Clinical Site Jupiter Florida
Kailera Clinical Site Miami Florida
Kailera Clinical Site Miami Lakes Florida
Kailera Clinical Site Orange City Florida
Kailera Clinical Site Orlando Florida
Kailera Clinical Site Orlando Florida
Kailera Clinical Site The Villages Florida
Kailera Clinical Site Decatur Georgia
Kailera Clinical Site Lilburn Georgia
Kailera Clinical Site Marietta Georgia
Kailera Clinical Site Riverdale Georgia
Kailera Clinical Site Skokie Illinois
Kailera Clinical Site Springfield Illinois
Kailera Clinical Site Newton Kansas
Kailera Clinical Site Shreveport Louisiana
Kailera Clinical Site Annapolis Maryland
Kailera Clinical Site Columbia Maryland
Kailera Clinical Site Boston Massachusetts
Kailera Clinical Site Farmington Hills Michigan
Kailera Clinical Site Missoula Montana
Kailera Clinical Site Lincoln Nebraska
Kailera Clinical Site Las Vegas Nevada
Kailera Clinical Site Albany New York
Kailera Clinical Site Laurelton New York
Kailera Clinical Site New York New York
Kailera Clinical Site Greensboro North Carolina
Kailera Clinical Site Monroe North Carolina

+ 133 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284901 on ClinicalTrials.gov ↗ ← All trials in the UK