CLEOPATTRANNC6019-0001 for Transthyretin Amyloid Cardiomyopathy

NNC6019-0001

Placebo (NNC6019-0001)

Number of occurrences of composite endpoint of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits)

Change in Kansas city cardiomyopathy questionnaire- clinical summary score (KCCQ-CSS)

Change in Kansas city cardiomyopathy questionnaire- overall summary score (KCCQ-OSS)

Change in 6-minute walk distance (6MWD)

Number of occurrences of CV events (CV hospitalisation and urgent HF visits)

Time to occurrence of CV death

Time to occurrence of all-cause death

Hierarchical composite of difference > 70 and > 30 meters in 6-minute walk test (6MWT) as assessed by the win ratio

Time to first occurrence of composite CKD endpoint: CV death, onset of a persistent decline in eGFR of ≥30% from baseline, onset of a persistent eGFR <15 mL/min/1.73 m^2, or initiation of chronic KRT, including dialysis or kidney transplantation

Time to hospitalisation due to HF or urgent HF visit

Time to CV events (CV hospitalisation and urgent HF visit)

Number of occurrences of composite endpoint of CV deaths and recurrent CV events (CV hospitalisation, urgent HF visits, and outpatient HF visits)

Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in KCCQ-CSS

Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in KCCQ-OSS

Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in 6-minute walk test (6MWT)

Change in stroke volume (SV)

Change in N-terminal pro B-type natriuretic peptide (NT-proBNP)

Change in high-sensitivity (hs) troponin I

Change in troponin T

Hierarchical composite of time to all-cause death as assessed by the win ratio

Hierarchical composite of number of CV events (CV hospitalisations or urgent HF visits) as assessed by the win ratio

Hierarchical composite of difference > 15, > 10 and > 5 points in KCCQ-OSS as assessed by the win ratio