Clinical trial

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Active, not recruiting · Phase 3 · 4 countries · Registry ID NCT06858878

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
ConditionType 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Full registry criteria

Inclusion Criteria: * Age ≥ 18 years. * Body mass index ≥ 27 kg/m\^2. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. * Diagnosis of T2DM. Exclusion Criteria: * Type 1 diabetes mellitus. * Self-reported change in body weight \> 5 kg within 90 days before screening. * Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment. * Obesity induced by other endocrinologic disorders. * 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 adminstered SC.

Placebo

Drug

Placebo will be adminstered SC.

Primary outcomes

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

Study locations

187 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 Viamonte🇦🇷 CABA, Buenos Aires, Argentina
Consultorios Medicos Dr Besada🇦🇷 CABA, Buenos Aires, Argentina
Maffei Centro Medico🇦🇷 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
Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD🌐 Pleven, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD🌐 Sofia, Bulgaria
Diagnostic - Consultative Center XX - Sofia EOOD🌐 Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD🌐 Sofia, Bulgaria
Prevencia-2000-Medical center for outpatient medical aid OOD🌐 Stara Zagora, Bulgaria
Medical Center Berbatov EOOD🌐 Yambol, Bulgaria
Aggarwal and Associates Ltd🇨🇦 Brampton, Ontario, Canada
Centricity Research Brampton🇨🇦 Brampton, Ontario, Canada
Centricity Research Vaughan🇨🇦 Concord, Ontario, Canada
Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre🇨🇦 Halifax, Nova Scotia, Canada
Premier Clinical Trial Network🇨🇦 Hamilton, Ontario, Canada
Winterberry Family Medicine🇨🇦 Hamilton, Ontario, Canada
Milestone Research🇨🇦 London, Ontario, Canada
Centricity Research Quebec City🇨🇦 Lévis, Quebec, Canada
Centre Medical Acadie🇨🇦 Montreal, Quebec, Canada
Institut de recherches cliniques de Montreal🇨🇦 Montreal, Quebec, Canada
Centricity Research Ottawa LMC🇨🇦 Nepean, Ontario, Canada
Your Research Network Inc.🇨🇦 Niagara Falls, Ontario, Canada
North York Diagnostic and Cardiac Centre🇨🇦 North York, Ontario, Canada
Centricity Research Pointe-Claire🇨🇦 Pointe-Claire, Quebec, Canada
Bluewater Clinical Research Group Incorporated🇨🇦 Sarnia, Ontario, Canada
tlc Diabetes and Endocrinology🇨🇦 Surrey, British Columbia, Canada
Albion Finch Medical Centre🇨🇦 Toronto, Ontario, Canada
Diex Recherche Trois Rivieres🇨🇦 Trois-Rivières, Quebec, Canada
Chronic Disease Innovation Centre🇨🇦 Winnipeg, Manitoba, Canada
Fakultni nemocnice Brno🇨🇿 Brno, Czechia
CCR Ostrava sro🇨🇿 Ostrava, Czechia
Diahelp sro🇨🇿 Pardubice, Czechia
Pratia Pardubice as🇨🇿 Pardubice, Czechia
Endokrinologie Cerny Most sro🇨🇿 Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady🇨🇿 Prague, Czechia
Institut klinicke a experimentalni mediciny🇨🇿 Prague, Czechia
Milan Kvapil sro🇨🇿 Prague, Czechia