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

NCT07284875

RecruitingPhase 3

Sponsor: Kailera

Conditions: Obesity, Overweight

Interventions: Ribupatide, Placebo

Countries: United States, Argentina, Australia, Bulgaria, Czechia, Germany, New Zealand, Poland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (88)
  • Anniston, Alabama, United States
  • Birmingham, Alabama, United States
  • Cullman, Alabama, United States
  • Sun City, Arizona, United States
  • Escondido, California, United States
  • Toluca Lake, California, United States
  • Aurora, Colorado, United States
  • Bridgeport, Connecticut, United States
  • Jupiter, Florida, United States
  • Lilburn, Georgia, United States
  • Springfield, Illinois, United States
  • Columbia, Maryland, United States
  • Las Vegas, Nevada, United States
  • Rochester, New York, United States
  • Morehead City, North Carolina, United States
  • Chickasha, Oklahoma, United States
  • Mauldin, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Amarillo, Texas, United States
  • Bellaire, Texas, United States
  • DeSoto, Texas, United States
  • Tomball, Texas, United States
  • Salt Lake City, Utah, United States
  • Danville, Virginia, United States
  • San Nicolás de los Arroyos, Buenos Aires, Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Godoy Cruz, Mendoza Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • + 58 more on CT.gov