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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
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Calgary_Cardiology
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CalgaryCanadaUnknown status
Ctr for Cardiovascular Innovation
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VancouverCanadaUnknown status
II. interni klinika VFN - Kardiologie a angiologie
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PragueCzechiaUnknown status
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
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HeidelbergGermanyUnknown status
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
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HeidelbergGermanyUnknown status
LMU Klinikum München Klinik und Poliklinik 1
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MünchenGermanyUnknown status
Uniklinik Münster, Klinik für Kardiologie I
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MünsterGermanyUnknown status
Universitätsklinikum Münster - Klinik für Kardiologie I
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MünsterGermanyUnknown status
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
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WürzburgGermanyUnknown status
Universitätsklinikum Würzburg AÖR
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WürzburgGermanyUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainUnknown status
AP-HP Hopital Henri Mondor
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CréteilFranceUnknown status
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
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ToulouseFranceUnknown status
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
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ToulouseFranceUnknown status
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Fondazione CNR-Regione Toscana Gabriele Monasterio
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PisaItalyUnknown status
Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare
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PisaItalyUnknown status
Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
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FukuokaJapanUnknown status
Hiroshima University hospital, Cardiovascular Medicine
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HiroshimaJapanUnknown status
Kumamoto University Hospital, Cardiovascular Medicine
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Kumamoto-shi, KumamotoJapanUnknown status
Shinshu University Hospital, Department of Neurology
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NaganoJapanUnknown status
Nagasaki University Hospital, Cardiovascular Medicine
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NagasakiJapanUnknown status
Okayama University Hospital_Cardiovascular Medicine
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OkayamaJapanUnknown status
UMC Groningen
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GroningenNetherlandsUnknown status
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsUnknown status
UMC Utrecht
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UtrechtNetherlandsUnknown status
Hospital Da Senhora Da Oliveira Guimarăes
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GuimarãesPortugalUnknown status
ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
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GuimarãesPortugalUnknown status
ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real
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Vila RealPortugalUnknown status
Univ of MD Schl of Med
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BaltimoreUnited StatesUnknown status
NW Univ-Bluhm Cardiovasc Inst
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ChicagoUnited StatesUnknown status
NW Univ-Bluhm Cardiovasc Inst
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EvanstonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Cedars-Sinai Medical Center_Los Angeles
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Los AngelesUnited StatesUnknown status
Mayo Clinic - Arizona
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PhoenixUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Stanford Hlth Cre-Boswell Clin
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StanfordUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.