Ireland
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Active, not recruiting Phase 3

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

NCT07284979 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2025-12-30
Last updated
2026-10-06

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Ribupatide →Semaglutide →Placebo

Ribupatide: SC Injection

Semaglutide: 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 semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Percent Change From Baseline in Body Weight at Week 76 — Baseline, Week 76

Trial sites (60)

FacilityCityRegionStatus
Kailera Clinical Site Glendale Arizona
Kailera Clinical Site Phoenix Arizona
Kailera Clinical Site Little Rock Arkansas
Kailera Clinical Site Northridge California
Kailera Clinical Site Oceanside California
Kailera Clinical Site Hamden Connecticut
Kailera Clinical Site Stamford Connecticut
Kailera Clinical Site Orange City Florida
Kailera Clinical Site Albany Georgia
Kailera Clinical Site Chicago Illinois
Kailera Clinical Site Skokie Illinois
Kailera Clinical Site Newton Kansas
Kailera Clinical Site Shreveport Louisiana
Kailera Clinical Site Farmington Hills Michigan
Kailera Clinical Site Missoula Montana
Kailera Clinical Site Las Vegas Nevada
Kailera Clinical Site Albany New York
Kailera Clinical Site Morehead City North Carolina
Kailera Clinical Site Morrisville North Carolina
Kailera Clinical Site Norman Oklahoma
Kailera Clinical Site East Greenwich Rhode Island
Kailera Clinical Site North Charleston South Carolina
Kailera Clinical Site Spartanburg South Carolina
Kailera Clinical Site Brownsville Texas
Kailera Clinical Site #1 San Antonio Texas
Kailera Clinical Site #2 San Antonio Texas
Kailera Clinical Site Manassas Virginia
Kailera Clinical Site Richmond Virginia
Kailera Clinical Site Bruce Australian Capital Territory
Kailera Clinical Site Blacktown New South Wales
Kailera Clinical Site Kanwal New South Wales
Kailera Clinical Site Herston Queensland
Kailera Clinical Site Morayfield Queensland
Kailera Clinical Site South Brisbane Queensland
Kailera Clinical Site Camberwell Victoria
Kailera Clinical Site Pleven Pleven Province
Kailera Clinical Site Plovdiv Plovdiv Province
Kailera Clinical Site Sofia Sofia
Kailera Clinical Site Sofia Sofia
Kailera Clinical Site Varna Varna Province

+ 20 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 NCT07284979 on ClinicalTrials.gov ↗ ← All trials in the USA