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Active, not recruiting Phase 3

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

NCT07284875 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2025-12-18
Last updated
2026-10-06

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Ribupatide →Placebo

Ribupatide: SC Injection

Placebo: SC Injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

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

Trial sites (110)

FacilityCityRegionStatus
Kailera Clinical Site Anniston Alabama
Kailera Clinical Site Birmingham Alabama
Kailera Clinical Site Cullman Alabama
Kailera Clinical Site Sun City Arizona
Kailera Clinical Site Escondido California
Kailera Clinical Site Toluca Lake California
Kailera Clinical Site Aurora Colorado
Kailera Clinical Site Bridgeport Connecticut
Kailera Clinical Site Jupiter Florida
Kailera Clinical Site Lilburn Georgia
Kailera Clinical Site Springfield Illinois
Kailera Clinical Site Columbia Maryland
Kailera Clinical Site Las Vegas Nevada
Kailera Clinical Site Rochester New York
Kailera Clinical Site Morehead City North Carolina
Kailera Clinical Site Chickasha Oklahoma
Kailera Clinical Site Mauldin South Carolina
Kailera Clinical Site Chattanooga Tennessee
Kailera Clinical Site Amarillo Texas
Kailera Clinical Site Bellaire Texas
Kailera Clinical Site DeSoto Texas
Kailera Clinical Site Tomball Texas
Kailera Clinical Site Salt Lake City Utah
Kailera Clinical Site Danville Virginia
Kailera Clinical Site La Plata Buenos Aires
Kailera Clinical Site #1 San Nicolás de los Arroyos Buenos Aires
Kailera Clinical Site #2 San Nicolás de los Arroyos Buenos Aires
Kailera Clinical Site #1 Buenos Aires Buenos Aires F.D.
Kailera Clinical Site #2 Buenos Aires Buenos Aires F.D.
Kailera Clinical Site Buenos Aires Buenos Aires F.D.
Kailera Clinical Site Buenos Aires Buenos Aires F.D.
Kailera Clinical Site Godoy Cruz Mendoza Province
Kailera Clinical Site #1 Rosario Santa Fe Province
Kailera Clinical Site #2 Rosario Santa Fe Province
Kailera Clinical Site #3 Rosario Santa Fe Province
Kailera Clinical Site CABA Argentina
Kailera Clinical Site Córdoba Argentina
Kailera Clinical Site Charlestown New South Wales
Kailera Clinical Site Sydney New South Wales
Kailera Clinical Site Sydney New South Wales

+ 70 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 NCT07284875 on ClinicalTrials.gov ↗ ← All trials in the USA