NIPH Clinical Trials Search

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atherosclerotic Cardiovascular Disease Overweight Obesity
Date of first enrollment	25/07/2025
Target sample size	12800
Countries of recruitment	Australia,Japan,Canada,Japan,Puerto Rico,Japan,South Korea,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Experimental: Maridebart Cafraglutide Participants will receive maridebart cafraglutide subcutaneously (SC). Interventions: Drug: Maridebart Cafraglutide Placebo Comparator: Placebo Participants will receive placebo SC. Interventions: Drug: Placebo

Outcome(s)

Primary Outcome

1. 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]) [Time Frame: Up to approximately 35 months]2. 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) [Time Frame: Up to approximately 35 months]

Secondary Outcome

1. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event [Time Frame: Up to approximately 35 months] 2. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization [Time Frame: Up to approximately35 months] 3. Time to First MI [Time Frame: Up to approximately 35 months] 4. Time to First Ischemic Stroke [Time Frame: Up to approximately 35 months] 5. Time to CV Death [Time Frame: Up to approximately 35 months] 6. Time to All-cause Death [Time Frame: Up to approximately 35 months] 7. Time to First Coronary Revascularization [Time Frame: Up to approximately 35 months] 8. Time to First HF Event [Time Frame: Up to approximately 35 months] 9. Time to First HF Event or CV Death [Time Frame: Up to approximately 35 months] 10. Time to First Unstable Angina Requiring Hospitalization [Time Frame: Up to approximately 35 months] 11. Time to First Occurrence of MI or CV Death [Time Frame: Up to approximately 35 months] 12. Time to First Occurrence of MI, Ischemic Stroke or All-cause Death [Time Frame: Up to approximately 35 months] 13. Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke) [Time Frame: Up to approximately 35 months] 14. Total All-cause Hospitalizations (Time to First and Recurrent Event) [Time Frame: Up to approximately 35 months] 15. Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline [Time Frame: Up to approximately 35 months] 16. Time to Onset of T2DM in Participants without T2DM at Baseline [Time Frame: Up to approximately 35 months] 17. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 [Time Frame: Baseline and Week 72] 18. Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72 [Time Frame: Baseline and Week 72] 19. Change from Baseline in Body Mass Index (BMI) at Week 72 [Time Frame: Baseline and Week 72] 20. Change from Baseline in Waist Circumference at Week 72 [Time Frame: Baseline and Week 72] 21. Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 [Time Frame: Baseline and Week 72] 22. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 [Time Frame: Baseline and Week 72] 23. Change from Baseline in Fasting Plasma Glucose at Week 72 [Time Frame: Baseline and Week 72] 24. Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72 [Time Frame: Baseline and Week 72] 25. Percent Change from Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72] 26. Percent Change from Baseline in Total Cholesterol at Week 72 [Time Frame: Baseline and Week 72] 27. Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72 [Time Frame: Baseline and Week 72] 28. Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72 [Time Frame: Baseline and Week 72] 29. Percent Change from Baseline in Triglycerides (TG) at Week 72 [Time Frame: Baseline and Week 72] 30. Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline [Time Frame: Baseline and Week 72] 31. Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline [Time Frame: Baseline and Week 72] 32. Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline [Time Frame: Baseline and Week 72] 33. Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline [Time Frame: Baseline and Week 72] 34. Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline [Time Frame: Baseline and Week 72] 35. Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline [Time Frame: Baseline and Week 72] 36. Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c >= 5.7% and < 6.5% at Baseline [Time Frame: Baseline and Week 72] 37. Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48 [Time Frame: Baseline and Week48] 38. Time to First Event of a Composite Nephropathy Endpoint [Time Frame: Up to approximately 35 months] Composite endpoint consists of onset of persistent macroalbuminuria, persistent >= 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR < 15 mL/min/1.73 m2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death. 39. Change in eGFR (total slope) for the period from baseline to the final follow up visit [Time Frame: Baseline up to approximately 35 months] 40. Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit [Time Frame: From 4 months up to approximately 35 months] 41. Time to First Occurrence of a Major Adverse Limb Event (MALE) Defined as Acute Limb Ischemia, Urgent Peripheral Revascularization, Major Amputation Due toa Vascular Etiology or Chronic Limb-threatening Ischemia Requiring Revascularization [Time Frame: Up to approximately 35 months] 42. Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event) [Time Frame: Up to approximately 35months] 43. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization [Time Frame: Up to approximately 35 months] 44. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia [Time Frame: Up to approximately 35months] 45. Time to First Occurrence of a Composite Endpoint Consisting of CV Death, MI, Ischemic Stroke, Acute Limb Ischemia, or Urgent Arterial Revascularization Procedure (Coronary, Cerebrovascular or Peripheral) [Time Frame: Up to approximately 35 months] 46. Number of Participants with Treatment-emergent Adverse Events [Time Frame: Up to approximately 35 months] 47. Number of Participants with Serious Adverse Events [Time Frame: Up to approximately 35 months] 48. Plasma Concentration of Maridebart Cafraglutide at Week 72 [Time Frame: Week 72]

Key inclusion & exclusion criteria

Age minimum	>= 45age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Age >= 45 years at screening. 2. BMI of >= 27 kg/m2 at screening. 3. History of Atherosclerotic Cardiovascular Disease (ASCVD) as evidenced by at least one of the following: - Prior MI. - Prior ischemic stroke (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.
Exclude criteria	1. History of any of the following within 60 days before screening: MI, hospitalization for unstable angina, coronary artery revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or transient ischemic attack (TIA). 2. New York Heart Association (NYHA) class IV HF at screening or hospitalization for HF within 60 days before screening. 3. Type 1 DM, or any type of diabetes with the exception of T2DM or history of gestational diabetes. 4. For participants with a prior diagnosis of T2DM at screening: - HbA1c > 10.0% (86 mmol/mol) at screening. - History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before screening. - One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness. - History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy. 5. 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 study. 6. History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening. 7. Family (first-degree relative[s]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2). 8. Calcitonin >= 50 ng/L (pg/mL) at screening. 9. 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), or total bilirubin (TBL) > 1.8 x ULN (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL). 10. History of malignancy within the last 5 years before screening (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). 11. Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.