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
Sites (38)
Sites in registry order. Save your city in your profile 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 |
| 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 |
| Universitätsklinikum Münster - Klinik für Kardiologie I Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitätsklinikum Würzburg AÖR Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Madrid | Spain | 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 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Coordinator of this site? Confirm its status | Toulouse Cedex 9 TSA 50032 | 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 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 |
| Hospital of the University of Occupational and Environmental Health 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-shi, Okayama | Japan | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| UMC Groningen afdeling Cardiologie 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 |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | 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 |
| Hospital Da Senhora Da Oliveira Guimarăes 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 |
| University of Maryland School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Univ of MD Schl of Med Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Cedars-Sinai Medical Center_Los Angeles Coordinator of this site? Confirm its status | Beverly Hills | 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 |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Oregon Hlth Sci Univ-Portland Coordinator of this site? Confirm its status | Portland | 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 |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.