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MARITIME-CVNCT07037433

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Primary completion (estimated)
Track this trial

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Record History

All 32 versions: 32 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Study sites revised (783)
  2. Study sites revised (783)
  3. Site details revised at 9 of 783 sites
  4. Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 8 of 48 entries
    • Site details revised at 7 of 783 sites
  5. Study sites: 782 to 783v28
  6. Study sites: 781 to 782v27
  7. Trial sites expanded: 774 → 781 locationsv26
  8. Study sites: 772 to 774v25
  9. Trial sites expanded: 769 → 772 locationsv24
  10. Trial sites expanded: 766 → 769 locationsv23
  11. Study sites: 765 to 766v22
  12. Trial sites expanded: 759 → 765 locationsv21
  13. Study sites: 758 to 759v20
  14. Trial sites expanded: 726 → 758 locationsv19
  15. Study sites: 714 to 726
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints: details revised at 1 of 48 entries
    v18
  16. Study sites: 708 to 714v17
  17. Study sites: 698 to 708v16
  18. Study sites: 670 to 698v15
  19. Study sites: 487 to 670v14
  20. Study sites: 359 to 487v13
  21. Study sites: 162 to 359v12
  22. Study sites: 139 to 162v11
  23. Study sites: 126 to 139v10
  24. Study sites: 117 to 126v9
  25. Study sites: 110 to 117v8
  26. Study sites: 102 to 110v7
  27. Study sites: 77 to 102v6
  28. Study sites: 57 to 77v5
  29. Study sites: 21 to 57
    • Start date changed from estimate of Jul 29, 2025 to Jul 25, 2025
    v4
  30. Study sites: 12 to 21v3
  31. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 12
    v2
  32. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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])
Timeframe: 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)
Timeframe: Up to approximately 35 months

Secondary (48)

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization
Time to First MI
Time to First Ischemic Stroke
Time to CV Death
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Time to All-cause Death
Time to First Coronary Revascularization
Time to First HF Event
Time to First HF Event or CV Death
Time to First Unstable Angina Requiring Hospitalization
Time to First Occurrence of MI or CV Death
Time to First Occurrence of MI, Ischemic Stroke or All-cause Death
Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke)
Total All-cause Hospitalizations (Time to First and Recurrent Event)
Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline
Time to Onset of T2DM in Participants without T2DM at Baseline
Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72
Change from Baseline in Waist Circumference at Week 72
Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Change from Baseline in Fasting Plasma Glucose at Week 72
Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72
Percent Change from Baseline in Body Weight at Week 72
Percent Change from Baseline in Total Cholesterol at Week 72
Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72
Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
Percent Change from Baseline in Triglycerides (TG) at Week 72
Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline
Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c ≥ 5.7% and < 6.5% at Baseline
Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48
Time to First Event of a Composite Nephropathy Endpoint
Change in eGFR (total slope) for the period from baseline to the final follow up visit
Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit
Time to First Occurrence of a Major Adverse Limb Event (MALE) Defined as Acute Limb Ischemia, Urgent Peripheral Revascularization, Major Amputation Due to a Vascular Etiology or Chronic Limb-threatening Ischemia Requiring Revascularization
Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event)
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia
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)
Number of Participants with Treatment-emergent Adverse Events
Number of Participants with Serious Adverse Events
Plasma Concentration of Maridebart Cafraglutide at Week 72

Arms and interventions

Maridebart CafraglutideExperimental

Participants will receive maridebart cafraglutide subcutaneously (SC).

PlaceboPlacebo comparator

Participants will receive placebo SC.

Drugs: Maridebart Cafraglutide, Placebo

Sites

783 sites in 36 countries

United States 140, Czechia 41, China 40, Germany 39, Poland 39, Brazil 37, Spain 33, Hungary 32, Japan 32, Netherlands 31, Argentina 30, United Kingdom 28, Slovakia 20, Turkey (Türkiye) 20, Australia 18, Canada 17, France 16, Romania 15, Greece 14, South Korea 14, Denmark 13, Italy 13, Belgium 12, Mexico 11, Bulgaria 10, Portugal 10, Austria 9, Taiwan 8, Chile 7, Sweden 7, Colombia 6, Finland 6, Singapore 6, Switzerland 6, Hong Kong 2, Puerto Rico 1