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

Recruiting · NCT07284875 · Interventional (participants receive a specific treatment) · Lead sponsor: Kailera

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

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.

Where it is running

60 locations listed across 18 US states.

Kailera Clinical Site - Anniston, Alabama, United States
Kailera Clinical Site - Birmingham, Alabama, United States
Kailera Clinical Site - Cullman, Alabama, United States
Kailera Clinical Site - Sun City, Arizona, United States
Kailera Clinical Site - Escondido, California, United States
Kailera Clinical Site - Toluca Lake, California, United States
Kailera Clinical Site - Aurora, Colorado, United States
Kailera Clinical Site - Bridgeport, Connecticut, United States
Kailera Clinical Site - Jupiter, Florida, United States
Kailera Clinical Site - Lilburn, Georgia, United States
Kailera Clinical Site - Springfield, Illinois, United States
Kailera Clinical Site - Columbia, Maryland, United States
Kailera Clinical Site - Las Vegas, Nevada, United States
Kailera Clinical Site - Rochester, New York, United States
Kailera Clinical Site - Morehead City, North Carolina, United States
Kailera Clinical Site - Chickasha, Oklahoma, United States
Kailera Clinical Site - Mauldin, South Carolina, United States
Kailera Clinical Site - Chattanooga, Tennessee, United States
Kailera Clinical Site - Amarillo, Texas, United States
Kailera Clinical Site - Bellaire, Texas, United States
Kailera Clinical Site - DeSoto, Texas, United States
Kailera Clinical Site - Tomball, Texas, United States
Kailera Clinical Site - Salt Lake City, Utah, United States
Kailera Clinical Site - Danville, Virginia, United States
Kailera Clinical Site - Auckland, New Zealand
Kailera Clinical Site - Barcelona, Spain
Kailera Clinical Site - CABA, Argentina
Kailera Clinical Site - Córdoba, Argentina
Kailera Clinical Site - Hamburg, Germany
Kailera Clinical Site - Hamburg, Germany
Kailera Clinical Site - Hodonín, Czechia
Kailera Clinical Site - Hounslow, United Kingdom
Kailera Clinical Site - London, United Kingdom
Kailera Clinical Site - Madrid, Spain
Kailera Clinical Site - Manchester, United Kingdom
Kailera Clinical Site - Nelson, New Zealand
Kailera Clinical Site - Olomouc, Czechia
Kailera Clinical Site - Pazardzhik, Bulgaria
Kailera Clinical Site - Plovdiv, Bulgaria
Kailera Clinical Site - Plovdiv, Bulgaria
Kailera Clinical Site - Prague, Czechia
Kailera Clinical Site - Schwerin, Germany
Kailera Clinical Site - Skierniewice, Poland
Kailera Clinical Site - Sofia, Bulgaria
Kailera Clinical Site - Sofia, Bulgaria
Kailera Clinical Site - Sofia, Bulgaria
Kailera Clinical Site - Uherské Hradiště, Czechia
Kailera Clinical Site - Valencia, Spain
Kailera Clinical Site - Varna, Bulgaria
Kailera Clinical Site - Yambol, Bulgaria
Kailera Clinical Site - Zamość, Poland
Kailera Clinical Site - Ferrol, A Coruna, Spain
Kailera Clinical Site - Seville, Andalusia, Spain
Kailera Clinical Site - Grafton, Auckland, New Zealand
Kailera Clinical Site - Silverdale, Auckland, New Zealand
Kailera Clinical Site - Tübingen, Baden-Wurttemberg, Germany
Kailera Clinical Site - Falkensee, Brandenburg, Germany
Kailera Clinical Site - La Plata, Buenos Aires, Argentina
Kailera Clinical Site - San Nicolás de los Arroyos, Buenos Aires, Argentina
Kailera Clinical Site - Buenos Aires, Buenos Aires F.D., Argentina

Showing 60 of 104 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →