The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

简要总结

主要结局

次要结局

• Change in waist-to-height ratio(From baseline (week 0) to 120 weeks)
• Change in systolic blood pressure (SBP)(From baseline (week 0) to 120 weeks)
• Time to first occurrence of a composite endpoint: Onset of persistent ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death and CV death(From baseline (week 0) to end of study (up to 242 weeks or more))
• Time to first occurrence of composite endpoint consisting of: Onset of persistent macro albuminuria, ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy and kidney death(From baseline (week 0) to end of study (up to 242 weeks or more))
• Time to first occurrence of an expanded 5-point MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation(From baseline (week 0) to end of study (up to 242 weeks or more))
• Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke(From baseline (week 0) to end of study (up to 242 weeks or more))
• Time to first occurrence of myocardial infarction (fatal and non-fatal)(From baseline (week 0) to end of study (up to 242 weeks or more))
• Time to first occurrence of stroke (fatal and non-fatal)(From baseline (week 0) to end of study (up to 242 weeks or more))
• Change in eGFRcr (CKD-EPI)(From baseline (week 0) to 120 weeks)
• Ratio to baseline in Urine albumin-to-creatinine ratio (UACR)(From baseline (week 0) to 120 weeks)
• Relative change in body weight(From baseline (week 0) to 120 weeks)
• Change in waist circumference(From baseline (week 0) to 120 weeks)
• Change in diastolic blood pressure (DBP)(From baseline (week 0) to 120 weeks)
• Ratio to baseline in lipids: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids(From baseline (week 0) to 120 weeks)
• Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to 120 weeks)
• Number of treatment emergent serious adverse events (TESAEs)(From baseline (week 0) to end of study (up to 242 weeks or more))
• Number of event adjudication committee (EAC)-confirmed malignant neoplasms(From baseline (week 0) to end of study (up to 242 weeks or more))
• Number of severe hypoglycaemic episodes (level 3) (only for participants with type 2 diabetes mellitus [T2D] at screening)(From baseline (week 0) to end of study (up to 242 weeks or more))