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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT07284875

Run by

Kailera

People needed

2340

Starts

2025-12-18

Expected to finish

2028-03-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
• hypertension,
• dyslipidemia,
• obstructive sleep apnea, or
• 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.

You may not qualify if…

• 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.

Where it is running

• Kailera Clinical Site — Birmingham, Alabama, United States (enrolling)
• Kailera Clinical Site — Cullman, Alabama, United States (enrolling)
• Kailera Clinical Site — Sun City, Arizona, United States (enrolling)
• Kailera Clinical Site — Escondido, California, United States (enrolling)
• Kailera Clinical Site — Toluca Lake, California, United States (enrolling)
• Kailera Clinical Site — Aurora, Colorado, United States (enrolling)
• Kailera Clinical Site — Bridgeport, Connecticut, United States (enrolling)
• Kailera Clinical Site — Jupiter, Florida, United States (enrolling)
• Kailera Clinical Site — Lilburn, Georgia, United States (enrolling)
• Kailera Clinical Site — Springfield, Illinois, United States (enrolling)
• Kailera Clinical Site — Columbia, Maryland, United States (enrolling)
• Kailera Clinical Site — Las Vegas, Nevada, United States (enrolling)
• Kailera Clinical Site — Rochester, New York, United States (enrolling)
• Kailera Clinical Site — Morehead City, North Carolina, United States (enrolling)
• Kailera Clinical Site — Chickasha, Oklahoma, United States (enrolling)
• Kailera Clinical Site — Mauldin, South Carolina, United States (enrolling)
• Kailera Clinical Site — Chattanooga, Tennessee, United States (enrolling)
• Kailera Clinical Site — Amarillo, Texas, United States (enrolling)
• Kailera Clinical Site — Bellaire, Texas, United States (enrolling)
• Kailera Clinical Site — DeSoto, Texas, United States (enrolling)
• Kailera Clinical Site — Tomball, Texas, United States (enrolling)
• Kailera Clinical Site — Salt Lake City, Utah, United States (enrolling)
• Kailera Clinical Site — Danville, Virginia, United States (enrolling)
• Kailera Clinical Site — San Nicolás de los Arroyos, Buenos Aires, Argentina (enrolling)
• Kailera Clinical Site — Anniston, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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