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Clinical Trials in the USA / NCT07458269
Active, not recruiting Phase 2

Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

NCT07458269 · tracked via the Priya Life Science USA tracker
Sponsor
Kailera
Phase
Phase 2
Started
2026-03-04
Last updated
2026-07-15

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

RibupatidePlacebo

Ribupatide: SC Injection

Placebo: SC Injection

Study summary

The primary objective of this study is to determine the effects of ribupatide administered by 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
Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers. * 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 within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
Kailera Clinical Site Mesa Arizona
Kailera Clinical Site Sun City West Arizona
Kailera Clinical Site Irvine California
Kailera Clinical Site Lake Forest California
Kailera Clinical Site Lomita California
Kailera Clinical Site Long Beach California
Kailera Clinical Site Montclair California
Kailera Clinical Site Rolling Hills Estates California
Kailera Clinical Site San Diego California
Kailera Clinical Site Santa Ana California
Kailera Clinical Site Van Nuys California
Kailera Clinical Site DeLand 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 Woodstock Georgia
Kailera Clinical Site Morton Illinois
Kailera Clinical Site Indianapolis Indiana
Kailera Clinical Site Louisville Kentucky
Kailera Clinical Site Rockville Maryland
Kailera Clinical Site St Louis Missouri
Kailera Clinical Site Lincoln Nebraska
Kailera Clinical Site Omaha Nebraska
Kailera Clinical Site East Syracuse New York
Kailera Clinical Site Greensboro North Carolina
Kailera Clinical Site Monroe North Carolina
Kailera Clinical Site Raleigh North Carolina
Kailera Clinical Site Greenville South Carolina
Kailera Clinical Site Myrtle Beach South Carolina
Kailera Clinical Site Knoxville Tennessee
Kailera Clinical Site Memphis Tennessee
Kailera Clinical Site Garland Texas
Kailera Clinical Site San Antonio Texas
Kailera Clinical Site Winchester Virginia

More Kailera trials in the USA

Other trials for the same condition

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 NCT07458269 on ClinicalTrials.gov ↗ ← All trials in the USA