Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM).

Conditions

The present study will include a population of patients with established ATTR CM.

Brief summary

Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 15 (week 52), Change in NT-proBNP from baseline (week 0) to visit 15 (week 52)

Detailed description

Change in myocardial extracellular volume (ECV) from baseline (week 0) to visit 15 (week 52), Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) from baseline (week 0) to visit 15 (week 52), Change in neuropathy impairment score (NIS) (only hATTR patients) from baseline (week 0) to visit 15 (week 52), Change in troponin I from baseline (week 0) to visit 15 (week 52), Change in global longitudinal strain (GLS) on echocardiography from baseline (week 0) to visit 15 (week 52), Number of treatment emergent adverse events from baseline (week 0) to visit 16 (week 64), Time to occurrence of all-cause mortality from baseline (week 0) to visit 16 (week 64), Number of CV events comprising hospitalisation due to CV events or urgent heart failure visits (week 0) to visit 16 (week 64)

Related papers

No related papers found yet.

Interventions

DRUGcoramitug

DRUGPlacebo (nnc6019-0001)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 15 (week 52), Change in NT-proBNP from baseline (week 0) to visit 15 (week 52)	—

Secondary

Measure	Time frame
Change in myocardial extracellular volume (ECV) from baseline (week 0) to visit 15 (week 52), Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) from baseline (week 0) to visit 15 (week 52), Change in neuropathy impairment score (NIS) (only hATTR patients) from baseline (week 0) to visit 15 (week 52), Change in troponin I from baseline (week 0) to visit 15 (week 52), Change in global longitudinal strain (GLS) on echocardiography from baseline (week 0) to visit 15 (week 52), Number of treatment emergent adverse events from baseline (week 0) to visit 16 (week 64), Time to occurrence of all-cause mortality from baseline (week 0) to visit 16 (week 64), Number of CV events comprising hospitalisation due to CV events or urgent heart failure visits (week 0) to visit 16 (week 64)	—

Measure

Time frame

Change in myocardial extracellular volume (ECV) from baseline (week 0) to visit 15 (week 52), Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) from baseline (week 0) to visit 15 (week 52), Change in neuropathy impairment score (NIS) (only hATTR patients) from baseline (week 0) to visit 15 (week 52), Change in troponin I from baseline (week 0) to visit 15 (week 52), Change in global longitudinal strain (GLS) on echocardiography from baseline (week 0) to visit 15 (week 52), Number of treatment emergent adverse events from baseline (week 0) to visit 16 (week 64), Time to occurrence of all-cause mortality from baseline (week 0) to visit 16 (week 64), Number of CV events comprising hospitalisation due to CV events or urgent heart failure visits (week 0) to visit 16 (week 64)

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Countries

Czechia, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed