Clinical trial
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Recruiting now · Phase 3 · 4 countries · Registry ID NCT07284901
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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
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 With Diabetes, Overweight With Diabetes
Full registry criteria
Key Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM). * Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive. * BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. * History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. * History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. * 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76Baseline, Week 76
Study locations
167 locations were listed when this page was built. The first 40 are shown.
Kailera Clinical Site🇦🇷 Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Córdoba, 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🇦🇷 Mar del Plata, Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Rosario, Santa Fe Province, Argentina
Kailera Clinical Site🇦🇷 Rosario, Sante Fe, Argentina
Kailera Clinical Site🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
Kailera Clinical Site🇦🇷 Zárate, Buenos Aires, Argentina
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🇦🇺 Charlestown, New South Wales, Australia
Kailera Clinical Site🇦🇺 Herston, Queensland, Australia
Kailera Clinical Site🇦🇺 Kanwal, New South Wales, Australia
Kailera Clinical Site🇦🇺 Leichhardt, New South Wales, Australia
Kailera Clinical Site🇦🇺 Melbourne, Victoria, Australia
Kailera Clinical Site🇦🇺 Morayfield, Queensland, Australia
Kailera Clinical Site🇦🇺 Penrith, New South Wales, Australia
Kailera Clinical Site🇦🇺 South Brisbane, 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🌐 Montana, Bulgaria
Kailera Clinical Site🌐 Pleven, Pleven Province, Bulgaria
Kailera Clinical Site🌐 Plovdiv, Plovdiv Province, Bulgaria
Kailera Clinical Site🌐 Rousse, Ruse Province, Bulgaria
Kailera Clinical Site🌐 Sofia, Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Sofia, Bulgaria
Kailera Clinical Site🌐 Sofia, Sofia, Bulgaria
Kailera Clinical Site🌐 Stara Zagora, Stara Zagora Province, Bulgaria
Kailera Clinical Site🌐 Varna, Varna Province, Bulgaria
Kailera Clinical Site🇨🇿 Bohnice, Prague, Czechia
Kailera Clinical Site🇨🇿 Brandýs nad Labem, Central Bohemia, Czechia