Clinical trial

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Recruiting now · Phase 3 · 5 countries · Registry ID NCT07284979

Recruiting nowPhase 3Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

Key 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.

Treatments and study arms

Ribupatide

Drug

SC Injection

Semaglutide

Drug

SC Injection

Placebo

Drug

SC Injection

Primary outcomes

Percent Change From Baseline in Body Weight at Week 76Baseline, Week 76

Study locations

59 locations were listed when this page was built. The first 40 are shown.

Kailera Clinical Site🇦🇺 Blacktown, New South Wales, Australia
Kailera Clinical Site🇦🇺 Bruce, Australian Capital Territory, Australia
Kailera Clinical Site🇦🇺 Camberwell, Victoria, Australia
Kailera Clinical Site🇦🇺 Herston, Queensland, Australia
Kailera Clinical Site🇦🇺 Kanwal, New South Wales, Australia
Kailera Clinical Site🇦🇺 Morayfield, Queensland, Australia
Kailera Clinical Site🇦🇺 South Brisbane, Queensland, Australia
Kailera Clinical Site🌐 Montana, Bulgaria
Kailera Clinical Site🌐 Pleven, Pleven Province, Bulgaria
Kailera Clinical Site🌐 Plovdiv, Plovdiv Province, Bulgaria
Kailera Clinical Site🌐 Sofia, Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Bulgaria
Kailera Clinical Site🌐 Stara Zagora, Bulgaria
Kailera Clinical Site🌐 Varna, Varna Province, Bulgaria
Kailera Clinical Site🇵🇱 Bydgoszcz, Poland
Kailera Clinical Site🇵🇱 Chorzów, Silesian Voivodeship, Poland
Kailera Clinical Site🇵🇱 Gdynia, Pomeranian Voivodeship, Poland
Kailera Clinical Site🇵🇱 Gdynia, Poland
Kailera Clinical Site🇵🇱 Kielce, Świętokrzyskie Voivodeship, Poland
Kailera Clinical Site🇵🇱 Krakow, Lesser Poland Voivodeship, Poland
Kailera Clinical Site🇵🇱 Warsaw, Masovian Voivodeship, Poland
Kailera Clinical Site🇵🇱 Wroclaw, Poland
Kailera Clinical Site🇬🇧 Exeter, Devon, United Kingdom
Kailera Clinical Site🇬🇧 Glasgow, Glasgow City, United Kingdom
Kailera Clinical Site🇬🇧 Leicester, Leicestershire, United Kingdom
Kailera Clinical Site🇬🇧 London, Greater London, United Kingdom
Kailera Clinical Site🇬🇧 London, Greater London, United Kingdom
Kailera Clinical Site🇬🇧 Rotherham, South Yorkshire, United Kingdom
Kailera Clinical Site🇬🇧 Torquay, Devon, United Kingdom
Kailera Clinical Site🇬🇧 Weymouth, Dorset, United Kingdom
Kailera Clinical Site🇺🇸 Albany, Georgia, United States
Kailera Clinical Site🇺🇸 Albany, New York, United States
Kailera Clinical Site🇺🇸 Brownsville, Texas, United States
Kailera Clinical Site🇺🇸 Chicago, Illinois, United States
Kailera Clinical Site🇺🇸 East Greenwich, Rhode Island, United States
Kailera Clinical Site🇺🇸 Farmington Hills, Michigan, United States
Kailera Clinical Site🇺🇸 Glendale, Arizona, United States
Kailera Clinical Site🇺🇸 Hamden, Connecticut, United States