Clinical trial
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Recruiting now · Phase 3 · 2 countries · Registry ID NCT07037433
Recruiting nowPhase 3Interventional
What this study is about
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.
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
Age45 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionAtherosclerotic Cardiovascular Disease, Overweight, Obesity
Full registry criteria
Inclusion Criteria * Age ≥ 45 years at screening. * BMI of ≥ 27.0 kg/m\^2 at screening. * History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following: * Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). * Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation). * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease. Exclusion Criteria * History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA). * New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization. * Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification. * For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening): * HbA1c \> 10.0% (86 mmol/mol) at screening. * History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization. * One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness. * History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema. * Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial. * History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization. * Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2). * Calcitonin ≥ 50 ng/L (pg/mL) at screening. * Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL). * History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ). * Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
Treatments and study arms
Maridebart Cafraglutide
Drug
Maridebart cafraglutide will be administered SC.
Placebo
Drug
Placebo will be administered SC.
Primary outcomes
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])Up to approximately 35 months
Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE)Up to approximately 35 months
Study locations
783 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
Centro Medico de Nutricion y Diabetes🇦🇷 CABA, Argentina
Conexa Investigacion Clinica SA🇦🇷 CABA, Buenos Aires, Argentina
Consultorios Medicos Dr Besada🇦🇷 CABA, Buenos Aires, Argentina
Fundacion Respirar - Consultorios Medicos Dr Doreski🇦🇷 CABA, Buenos Aires, Argentina
Glenny Corp SA🇦🇷 CABA, Buenos Aires, Argentina
Imoba Investigaciones medicas🇦🇷 CABA, Buenos Aires, Argentina
Stat Research🇦🇷 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
Centro Diabetologico Dr Waitman🇦🇷 Córdoba, Córdoba Province, Argentina
Clinica Privada del Prado🇦🇷 Córdoba, Córdoba Province, Argentina
Instituto Medico Damic🇦🇷 Córdoba, Argentina
CIPADi🇦🇷 Godoy Cruz, Mendoza Province, Argentina
Hospital Italiano de La Plata🇦🇷 La Plata, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata🇦🇷 Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones clinicas de Mar del Plata🇦🇷 Mar del Plata, Buenos Aires, Argentina
Dim Clinica Privada🇦🇷 Ramos Meija, Buenos Aires, Argentina
INECO Neurociencias Oronio🇦🇷 Rosario, Argentina
Instituto Medico Catamarca Imec🇦🇷 Rosario, Santa Fe Province, Argentina
Instituto Medico Rio Cuarto SA🇦🇷 Río Cuarto, Córdoba Province, Argentina
Instituto de Investigaciones Clinicas de San Nicolas🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
Centro de Investigaciones Clinicas del Litoral🇦🇷 Santa Fe, Argentina
mit - Medicina Investigacion y Tratamiento🇦🇷 Santa Rosa, La Pampa Province, Argentina
Clinica Fusavim Privada SRL🇦🇷 Villa María, Córdoba Province, Argentina
Go Centro Medico San Nicolas🇦🇷 Zárate, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate🇦🇷 Zárate, Buenos Aires, Argentina
Advara HeartCare Wesley🇦🇺 Auchenflower, Queensland, Australia
Flinders Medical Centre🇦🇺 Bedford Park, South Australia, Australia
Novatrials🇦🇺 Charlestown, New South Wales, Australia
Victorian Heart Hospital🇦🇺 Clayton, Victoria, Australia
Momentum Clinical Research - Darlinghurst🇦🇺 Darlinghurst, New South Wales, Australia
Barwon Health Geelong Hospital🇦🇺 Geelong, Victoria, Australia
Austin Health, Heidelberg Repatriation Hospital🇦🇺 Heidelberg West, Victoria, Australia
Royal Brisbane and Womens Hospital🇦🇺 Herston, Queensland, Australia
Advara HeartCare Joondalup🇦🇺 Joondalup, Western Australia, Australia
Advara HeartCare Leabrook🇦🇺 Leabrook, South Australia, Australia