Transthyretin Amyloid Cardiomyopathy Clinical Trial

A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis

Summary

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Exclusion Criteria:

A prior solid organ transplant.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT06260709

Recruitment Status:

Recruiting

Sponsor:

Novo Nordisk A/S

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There are 23 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
Cedars-Sinai Medical Center_Los Angeles
Los Angeles California, 90048, United States
Stanford Hlth Cre-Boswell Clin
Stanford California, 94305, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
NW Univ-Bluhm Cardiovasc Inst
Evanston Illinois, 60208, United States
Univ of MD Schl of Med
Baltimore Maryland, 21201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
University of Calgary_Cardiology
Calgary Alberta, T2N 4, Canada
Ctr for Cardiovascular Innovation
Vancouver British Columbia, V5Z 1, Canada
II. interni klinika VFN - Kardiologie a angiologie
Praha 2 , 12808, Czechia
Ap-Hp-Hopital Henri Mondor
Créteil , 94000, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
Toulouse Cedex 9 , 31059, France
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
Heidelberg , 69120, Germany
LMU Klinikum München Klinik und Poliklinik 1
München , 81377, Germany
Uniklinik Münster, Klinik für Kardiologie I
Münster , 48149, Germany
Universitatsklinikum Wurzburg AöR
Würzburg , 97078, Germany
Fondazione CNR-Regione Toscana Gabriele Monasterio
Pisa Pi, 56124, Italy
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
Pavia PV, 27100, Italy
UMC Groningen
Groningen , 9713 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
Hospital da Senhora da Oliveira - Guimarães
Guimarães , 4835-, Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro
Vila Real , 5000-, Portugal
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT06260709

Recruitment Status:

Recruiting

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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