NCT06260709Active, not recruitingPhase 2
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
Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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 approximately 6 years or until NNC6019-0001 is commercially or otherwise available to the participant, whichever comes first.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 7 Feb 2024
- Start date
- 20 Feb 2024
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT06260709
- EU CT number
- 2022-502605-15-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 88
- From 20 Feb 2024 to the primary completion date, 29 Feb 2028
- 37 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A prior solid organ transplant.
Other illness
- 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.
Lab values
- 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.
Other
- Body weight greater than (\>) 120 kilograms (kg) (264.6 pounds \[lb\]) at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary_Cardiology Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ctr for Cardiovascular Innovation Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| II. interni klinika VFN - Kardiologie a angiologie Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| LMU Klinikum München Klinik und Poliklinik 1 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Uniklinik Münster, Klinik für Kardiologie I Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitätsklinikum Münster - Klinik für Kardiologie I Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Universitätsklinikum Würzburg AÖR Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| AP-HP Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Fondazione CNR-Regione Toscana Gabriele Monasterio Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hiroshima University hospital, Cardiovascular Medicine Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Kumamoto University Hospital, Cardiovascular Medicine Coordinator of this site? Confirm its status | Kumamoto-shi, Kumamoto | Japan | Unknown status |
| Shinshu University Hospital, Department of Neurology Coordinator of this site? Confirm its status | Nagano | Japan | Unknown status |
| Nagasaki University Hospital, Cardiovascular Medicine Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Okayama University Hospital_Cardiovascular Medicine Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Hospital Da Senhora Da Oliveira Guimarăes Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real Coordinator of this site? Confirm its status | Vila Real | Portugal | Unknown status |
| Univ of MD Schl of Med Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| NW Univ-Bluhm Cardiovasc Inst Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| NW Univ-Bluhm Cardiovasc Inst Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Cedars-Sinai Medical Center_Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Stanford Hlth Cre-Boswell Clin Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.