Clinical trial

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Active, not recruiting · Phase 3 · 5 countries · Registry ID NCT06858839

Active, not recruitingPhase 3Interventional

What this study is about

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for 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 99 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

Inclusion Criteria: * Age ≥ 18 years. * Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: * Type 1 or Typ2 diabetes mellitus. * Obesity induced by other endocrinologic disorders. * Self-reported change in body weight \> 5 kg within 90 days before screening. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. * Lifetime history of suicide attempt.

Treatments and study arms

Maridebart Cafraglutide

Drug

Maridebart cafraglutide will be administered SC.

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 72Baseline and Week 72

Study locations

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

Cedic - Centro de Investigacion Clinica🇦🇷 CABA, Buenos Aires, Argentina
Cemedic Centro de Especialidades Medicas🇦🇷 CABA, Buenos Aires, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada🇦🇷 CABA, Buenos Aires, Argentina
Centro Medico Viamonte🇦🇷 CABA, Buenos Aires, Argentina
Consultorios Medicos Dr Besada🇦🇷 CABA, Buenos Aires, Argentina
Fundacion Respirar🇦🇷 CABA, Buenos Aires, Argentina
Cinme - Centro de Investigaciones Metabolicas🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Ciprec - Centro de Investigacion y Prevencion Cardiovascular🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Emeritus Research Sydney🇦🇺 Botany, New South Wales, Australia
Emeritus Research Camberwell🇦🇺 Camberwell, Victoria, Australia
Novatrials🇦🇺 Charlestown, New South Wales, Australia
Austin Health, Heidelberg Repatriation Hospital🇦🇺 Heidelberg West, Victoria, Australia
Logan Hospital🇦🇺 Meadowbrook, Queensland, Australia
Canopy Clinical Sutherland🇦🇺 Miranda, New South Wales, Australia
Canopy Clinical Altona North🇦🇺 North Altona, Victoria, Australia
Fusion Clinical Research🇦🇺 Norwood, South Australia, Australia
Southern Adelaide Diabetes and Endocrine Services🇦🇺 Oaklands Park, South Australia, Australia
Royal North Shore Hospital🇦🇺 St Leonards, New South Wales, Australia
Canopy Clinical Wollongong🇦🇺 Wollongong, New South Wales, Australia
Universitair Ziekenhuis Antwerpen🇧🇪 Edegem, Belgium
Universitair Ziekenhuis Gent🇧🇪 Ghent, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan🇧🇪 Kortrijk, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg🇧🇪 Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman🇧🇪 Liège, Belgium
Algemeen Ziekenhuis Sint-Maarten🇧🇪 Mechelen, Belgium
Centres Hospitaliers Universitaires HELORA - Hôpital de Mons - Site Constantinople🇧🇪 Mons, Belgium
Ecogene-21🇨🇦 Chicoutimi, Quebec, Canada
Wharton Medical Clinic🇨🇦 Hamilton, Ontario, Canada
North York Diagnostic and Cardiac Centre🇨🇦 North York, Ontario, Canada
Centricity Research Oshawa Multispecialty🇨🇦 Oshawa, Ontario, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec🇨🇦 Québec, Quebec, Canada
CardioVasc HR Incorporated🇨🇦 Saint-Jean-sur-Richelieu, Quebec, Canada
Heart Health Institute Research Incorporated🇨🇦 Scarborough Village, Ontario, Canada
tlc Diabetes and Endocrinology🇨🇦 Surrey, British Columbia, Canada
Centre de Medecine Metabolique de Lanaudiere🇨🇦 Terrebonne, Quebec, Canada
Curans Heart Center🇨🇦 Thunder Bay, Ontario, Canada
Centricity Research Toronto🇨🇦 Toronto, Ontario, Canada
Diabetes Heart Research Centre🇨🇦 Toronto, Ontario, Canada
Medicus Services sro🇨🇿 Brandýs nad Labem, Czechia
Fakultni nemocnice Brno🇨🇿 Brno, Czechia