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NCT05442047CompletedPhase 2

A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
105 (actual)
First submitted
28 Jun 2022
Start date
2 Aug 2022
Primary completion date
17 Feb 2025
Lead sponsor
Novo Nordisk A/S
Diseases
Amyloidosis
NCT number
NCT05442047
EudraCT number
2021-006226-49

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 105
  • From 2 Aug 2022 to the primary completion date, 17 Feb 2025
  • 38 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.
  • Planned solid organ transplant during the study.

Other illness

  • Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy transthyretin amyloid cardiomyopathy (ATTR CM), for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
  • Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
  • History of contrast allergy or adverse reactions to gadolinium-containing agents.

Lab values

  • Current treatment with calcium channel blockers with conduction system effects (example \[e.g.\], 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 \>120 kilogram (kg) (264.6 pounds \[lb\]) at screening.

Who the study is looking for

  • Male or female.
  • Age greater than or equal to (\>=) 18 to less than (\<) 85 years at the time of signing informed consent.
  • Have an established diagnosis of Transthyretin amyloid cardiomyopathy (ATTR CM) with either wild-type transhyretin (TTR) or hereditary transthyretin (TTR) genotype as per local standards.
  • Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
  • Known end-diastolic interventricular septal wall thickness greater than or equal to (\>=) 12 millimeters (mm).
  • Presently classified as New York Heart Association (NYHA) Class II-III.
  • N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or equal to (\>=) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater than (\>) 1000 pg/mL in atrial fibrillation at screening.
  • Completed greater than or equal to (\>=) 150 meters to less than or equal to (\<=) 450 meters on the 6-minute walk test (MWT) at screening.
  • Estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at screening.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Save your city in your profile 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
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
Universitätsklinikum Münster - Klinik für Kardiologie I
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MünsterGermanyUnknown status
Universitätsklinikum Würzburg AÖR
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WürzburgGermanyUnknown status
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
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WürzburgGermanyUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda
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MadridSpainUnknown 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
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ToulouseFranceUnknown status
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
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Toulouse Cedex 9 TSA 50032FranceUnknown status
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown 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
Hospital of the University of Occupational and Environmental Health
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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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Okayama-shi, OkayamaJapanUnknown status
UMC Groningen
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GroningenNetherlandsUnknown status
UMC Groningen afdeling Cardiologie
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GroningenNetherlandsUnknown status
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsUnknown status
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalUnknown status
ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
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GuimarãesPortugalUnknown status
Hospital Da Senhora Da Oliveira Guimarăes
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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
University of Maryland School of Medicine
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BaltimoreUnited StatesUnknown status
Univ of MD Schl of Med
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BaltimoreUnited StatesUnknown status
Cedars-Sinai Medical Center_Los Angeles
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Beverly HillsUnited StatesUnknown status
NW Univ-Bluhm Cardiovasc Inst
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EvanstonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Mayo Clinic - Arizona
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PhoenixUnited StatesUnknown status
Oregon Hlth Sci Univ-Portland
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PortlandUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Stanford Hlth Cre-Boswell Clin
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StanfordUnited StatesUnknown status

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