Clinical trial

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 · 5 countries · Registry ID NCT07284875

Recruiting nowPhase 3Interventional

What this study 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.

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, Overweight

Full registry 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.

Treatments and study arms

Ribupatide

Drug

SC Injection

Placebo

Drug

SC Injection

Primary outcomes

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76Baseline, Week 76

Study locations

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

Kailera Clinical Site🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Kailera Clinical Site🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Kailera Clinical Site🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Kailera Clinical Site🇦🇷 CABA, Argentina
Kailera Clinical Site🇦🇷 Córdoba, Argentina
Kailera Clinical Site🇦🇷 Godoy Cruz, Mendoza Province, Argentina
Kailera Clinical Site🇦🇷 La Plata, Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Rosario, Santa Fe Province, Argentina
Kailera Clinical Site🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
Kailera Clinical Site🇦🇺 Charlestown, New South Wales, Australia
Kailera Clinical Site🇦🇺 Heidelberg Heights, Victoria, Australia
Kailera Clinical Site🇦🇺 Melbourne, Victoria, Australia
Kailera Clinical Site🇦🇺 Norwood, South Australia, Australia
Kailera Clinical Site🇦🇺 Sippy Downs, Queensland, Australia
Kailera Clinical Site🇦🇺 Sydney, New South Wales, Australia
Kailera Clinical Site🇦🇺 Sydney, New South Wales, Australia
Kailera Clinical Site🇦🇺 Sydney, New South Wales, Australia
Kailera Clinical Site🇦🇺 Wollongong, New South Wales, Australia
Kailera Clinical Site🌐 Kyustendil, Kyustendil Province, Bulgaria
Kailera Clinical Site🌐 Pazardzhik, Bulgaria
Kailera Clinical Site🌐 Plovdiv, Bulgaria
Kailera Clinical Site🌐 Plovdiv, Bulgaria
Kailera Clinical Site🌐 Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Bulgaria
Kailera Clinical Site🌐 Varna, Bulgaria
Kailera Clinical Site🌐 Yambol, Bulgaria
Kailera Clinical Site🇨🇿 Bohnice, Prague, Czechia
Kailera Clinical Site🇨🇿 Brandýs nad Labem, Central Bohemia, Czechia
Kailera Clinical Site🇨🇿 Brno, South Moravian, Czechia
Kailera Clinical Site🇨🇿 Hodonín, Czechia
Kailera Clinical Site🇨🇿 Krnov, Moravian-Silesian Region, Czechia
Kailera Clinical Site🇨🇿 Náchod, Hradec Králové Region, Czechia
Kailera Clinical Site🇨🇿 Olomouc, Czechia
Kailera Clinical Site🇨🇿 Prague, Prague, Czechia
Kailera Clinical Site🇨🇿 Prague, Prague, Czechia
Kailera Clinical Site🇨🇿 Prague, Czechia
Kailera Clinical Site🇨🇿 Uherské Hradiště, Czechia
Kailera Clinical Site🇩🇪 Cologne, North Rhine-Westphalia, Germany
Kailera Clinical Site🇩🇪 Dresden, Saxony, Germany