Transthyretin Amyloid Cardiomyopathy (ATTR CM)Phase 2NCT06260709
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
A Phase 2 study testing NNC6019-0001 in people with Transthyretin Amyloid Cardiomyopathy (ATTR CM), run by Novo Nordisk A/S at 38 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR CM)
- What is being tested?
- NNC6019-0001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 20 Feb 2024to 9 Feb 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States8 sites
Univ of MD Schl of Med
Baltimore, Maryland, 21201
NW Univ-Bluhm Cardiovasc Inst
Chicago, Illinois, 60611
NW Univ-Bluhm Cardiovasc Inst
Evanston, Illinois, 60208
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Cedars-Sinai Medical Center_Los Angeles
Los Angeles, California, 90048
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Stanford Hlth Cre-Boswell Clin
Stanford, California, 94305
Germany7 sites
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
Heidelberg, 69120
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
Heidelberg, 69120
LMU Klinikum München Klinik und Poliklinik 1
München, 81377
Uniklinik Münster, Klinik für Kardiologie I
Münster, 48149
Universitätsklinikum Münster - Klinik für Kardiologie I
Münster, 48149
Universitatsklinikum Wurzburg AöR
Würzburg, 97078
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
Würzburg, 97078
Japan7 sites
Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
Fukuoka, 807-8556
Hiroshima University hospital, Cardiovascular Medicine
Hiroshima, 734-8551
Hiroshima University hospital_Cardiovascular Medicine
Hiroshima, 734-8551
Kumamoto University Hospital, Cardiovascular Medicine
Kumamoto-shi, Kumamoto, 860-8556
Shinshu University Hospital, Department of Neurology
Nagano, 390-8621
Nagasaki University Hospital, Cardiovascular Medicine
Nagasaki, 852-8501
Okayama University Hospital_Cardiovascular Medicine
Okayama, 700-8558
France3 sites
Ap-Hp-Hopital Henri Mondor
Créteil, 94000
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
Toulouse, 31059
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
Toulouse, 31059
Italy3 sites
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Fondazione CNR-Regione Toscana Gabriele Monasterio
Pisa, Pi, 56124
Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare
Pisa, Pi, 56124
Netherlands3 sites
UMC Groningen
Groningen, 9713 GZ
UMC Utrecht
Utrecht, 3584 CX
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Portugal3 sites
Hospital da Senhora da Oliveira - Guimarães
Guimarães, 4835-044
ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
Guimarães, 4835-044
ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real
Vila Real, 5000-508
Canada2 sites
University of Calgary_Cardiology
Calgary, Alberta, T2N 4Z6
Ctr for Cardiovascular Innovation
Vancouver, British Columbia, V5Z 1M9
Czechia1 site
II. interni klinika VFN - Kardiologie a angiologie
Prague, 12808
Spain1 site
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
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.
- Being tested
- NNC6019-0001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC6019-0001Drug
Intravenous NNC6019-0001 every 4 weeks added to the standard of care up to 300 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NNC6019-0001 | Experimental | Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care up to 300 weeks. Receives: Drug: NNC6019-0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as events.
Measured: From baseline (week 0) to up to 6 years
Secondary outcomes (6)
Change in 6-Minute Walk Test (6MWT)
Measured in meters.
Measured: From baseline (week 0) to visit 28 (week 104)
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Measured in percentage.
Measured: From baseline (week 0) to visit 28 (week 104)
Change in Myocardial Extracellular Volume (ECV)
Measured in percentage-points.
Measured: From baseline (week 0) to visit 28 (week 104)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Measured in score on a scale.
Measured: From baseline (week 0) to visit 28 (week 104)
Change in Troponin I
Measured in nanogram per milliliter (ng/mL).
Measured: From baseline (week 0) to visit 28 (week 104)
Change in Global Longitudinal Strain (GLS) on Echocardiography
Measured in percentage-points.
Measured: From baseline (week 0) to visit 28 (week 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start20 Feb 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion9 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR CM)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260709
- Sponsor's protocol ID
- NN6019-7565
- Other IDs
- 2022-502605-15-00, U1111-1284-5820, jRCT2071240078
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com