Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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.
Кой може да участва
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.
Интервенции
Maridebart Cafraglutide
DRUG
Placebo
DRUG
Места на провеждане
759
Argentina (30)
Centro Medico Viamonte
CABA , Buenos Aires
Imoba Investigaciones medicas
CABA , Buenos Aires
Conexa Investigacion Clinica SA
CABA , Buenos Aires
Stat Research
CABA , Buenos Aires
Cedic - Centro de Investigacion Clinica
CABA , Buenos Aires
Cemedic Centro de Especialidades Medicas
CABA , Buenos Aires
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
CABA , Buenos Aires
Consultorios Medicos Dr Besada
CABA , Buenos Aires
Fundacion Respirar - Consultorios Medicos Dr Doreski
CABA , Buenos Aires
Glenny Corp SA
CABA , Buenos Aires
Centro Medico de Nutricion y Diabetes
CABA
Cinme - Centro de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires , Buenos Aires
Ciprec - Centro de Investigacion y Prevencion Cardiovascular
Ciudad Autonoma de Buenos Aires , Buenos Aires
Centro Diabetologico Dr Waitman
Córdoba , Córdoba Province
Clinica Privada del Prado
Córdoba , Córdoba Province
Instituto Medico Damic
Córdoba
CIPADi
Godoy Cruz , Mendoza Province
Hospital Italiano de La Plata
La Plata , Buenos Aires
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata , Buenos Aires
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata , Buenos Aires
Dim Clinica Privada
Ramos Meija , Buenos Aires
Instituto Medico Rio Cuarto SA
Río Cuarto , Córdoba Province
Instituto Medico Catamarca Imec
Rosario , Santa Fe Province
INECO Neurociencias Oronio
Rosario
Instituto de Investigaciones Clinicas de San Nicolas
San Nicolás de los Arroyos , Buenos Aires
Centro de Investigaciones Clinicas del Litoral
Santa Fe
mit - Medicina Investigacion y Tratamiento
Santa Rosa , La Pampa Province
Clinica Fusavim Privada SRL
Villa María , Córdoba Province
Go Centro Medico San Nicolas
Zárate , Buenos Aires
Instituto de Investigaciones Clinicas Zarate
Zárate , Buenos Aires
Австралия (18)
Advara HeartCare Wesley
Auchenflower , Queensland
Flinders Medical Centre
Bedford Park , South Australia
Novatrials
Charlestown , New South Wales
Victorian Heart Hospital
Clayton , Victoria
Barwon Health Geelong Hospital
Geelong , Victoria
Austin Health, Heidelberg Repatriation Hospital
Heidelberg West , Victoria
Royal Brisbane and Womens Hospital
Herston , Queensland
Advara HeartCare Joondalup
Joondalup , Western Australia
Advara HeartCare Leabrook
Leabrook , South Australia
The Alfred Hospital
Melbourne , Victoria
Core Research Group Pty Ltd
Milton , Queensland
Advara HeartCare Mulgrave
Mulgrave , Victoria
Fiona Stanley Hospital
Murdoch , Western Australia
Linear Clinical Research Limited
Nedlands , Western Australia
Royal North Shore Hospital
St Leonards , New South Wales
Momentum Clinical Research - Darlinghurst
Sydney , New South Wales
The Queen Elizabeth Hospital
Woodville South , South Australia
Dr Heart Pty Ltd
Woolloongabba , Queensland
Австрия (8)
Landeskrankenhaus Feldkirch
Feldkirch
Medizinische Universitaet Graz
Graz
Klinikum Klagenfurt am Woerthersee
Klagenfurt
Krankenhaus der Barmherzigen Brueder Linz
Linz
Klinik Landstrasse
Vienna
Zentrum fuer klinische Studien - Dr Hanusch GmbH
Vienna
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Klinik Hietzing
Vienna
Белгия (12)
Azorg Campus Aalst - Moorselbaan
Aalst
Imelda Ziekenhuis vzw
Bonheiden
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges
Cliniques universitaires de Bruxelles Hopital Erasme
Brussels
Universitair Ziekenhuis Antwerpen
Edegem
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk
Algemeen Ziekenhuis Sint Lucas
Ghent
Centres Hospitaliers Universitaires - Helora - Hopital de La Louviere - Site Jolimont
БГ
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