Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Recruiting · NCT07284979 · 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 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.
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 ≥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.
Where it is running
59 locations listed across 19 US states.
- Kailera Clinical Site - Glendale, Arizona, United States
- Kailera Clinical Site - Phoenix, Arizona, United States
- Kailera Clinical Site - Little Rock, Arkansas, United States
- Kailera Clinical Site - Northridge, California, United States
- Kailera Clinical Site - Oceanside, California, United States
- Kailera Clinical Site - Hamden, Connecticut, United States
- Kailera Clinical Site - Stamford, Connecticut, United States
- Kailera Clinical Site - Orange City, Florida, United States
- Kailera Clinical Site - Albany, Georgia, United States
- Kailera Clinical Site - Chicago, Illinois, United States
- Kailera Clinical Site - Skokie, Illinois, United States
- Kailera Clinical Site - Newton, Kansas, United States
- Kailera Clinical Site - Shreveport, Louisiana, United States
- Kailera Clinical Site - Farmington Hills, Michigan, United States
- Kailera Clinical Site - Missoula, Montana, United States
- Kailera Clinical Site - Las Vegas, Nevada, United States
- Kailera Clinical Site - Albany, New York, United States
- Kailera Clinical Site - Morehead City, North Carolina, United States
- Kailera Clinical Site - Morrisville, North Carolina, United States
- Kailera Clinical Site - Norman, Oklahoma, United States
- Kailera Clinical Site - East Greenwich, Rhode Island, United States
- Kailera Clinical Site - North Charleston, South Carolina, United States
- Kailera Clinical Site - Spartanburg, South Carolina, United States
- Kailera Clinical Site - Brownsville, Texas, United States
- Kailera Clinical Site - San Antonio, Texas, United States
- Kailera Clinical Site - Manassas, Virginia, United States
- Kailera Clinical Site - Richmond, Virginia, United States
- Kailera Clinical Site - Bydgoszcz, Poland
- Kailera Clinical Site - Gdynia, Poland
- Kailera Clinical Site - Montana, Bulgaria
- Kailera Clinical Site - Sofia, Bulgaria
- Kailera Clinical Site - Sofia, Bulgaria
- Kailera Clinical Site - Stara Zagora, Bulgaria
- Kailera Clinical Site - Wroclaw, Poland
- Kailera Clinical Site - Bruce, Australian Capital Territory, Australia
- Kailera Clinical Site - Exeter, Devon, United Kingdom
- Kailera Clinical Site - Torquay, Devon, United Kingdom
- Kailera Clinical Site - Weymouth, Dorset, United Kingdom
- Kailera Clinical Site - Glasgow, Glasgow City, United Kingdom
- Kailera Clinical Site - London, Greater London, United Kingdom
- Kailera Clinical Site - London, Greater London, United Kingdom
- Kailera Clinical Site - Leicester, Leicestershire, United Kingdom
- Kailera Clinical Site - Krakow, Lesser Poland Voivodeship, Poland
- Kailera Clinical Site - Warsaw, Masovian Voivodeship, Poland
- Kailera Clinical Site - Blacktown, New South Wales, Australia
- Kailera Clinical Site - Kanwal, New South Wales, Australia
- Kailera Clinical Site - Pleven, Pleven Province, Bulgaria
- Kailera Clinical Site - Plovdiv, Plovdiv Province, Bulgaria
- Kailera Clinical Site - Gdynia, Pomeranian Voivodeship, Poland
- Kailera Clinical Site - Herston, Queensland, Australia
- Kailera Clinical Site - Morayfield, Queensland, Australia
- Kailera Clinical Site - South Brisbane, Queensland, Australia
- Kailera Clinical Site - Chorzów, Silesian Voivodeship, Poland
- Kailera Clinical Site - Sofia, Sofia, Bulgaria
- Kailera Clinical Site - Sofia, Sofia, Bulgaria
- Kailera Clinical Site - Rotherham, South Yorkshire, United Kingdom
- Kailera Clinical Site - Varna, Varna Province, Bulgaria
- Kailera Clinical Site - Camberwell, Victoria, Australia
- Kailera Clinical Site - Kielce, Świętokrzyskie Voivodeship, Poland