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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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
Are there results?
Not yet: the study is under way

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

Other trials in United States

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

Other trials in Germany

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

Other trials in Japan

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

Other trials in France

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

Other trials in Italy

Netherlands3 sites

  • UMC Groningen

    Groningen, 9713 GZ

  • UMC Utrecht

    Utrecht, 3584 CX

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

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

Other trials in Portugal

Canada2 sites

  • University of Calgary_Cardiology

    Calgary, Alberta, T2N 4Z6

  • Ctr for Cardiovascular Innovation

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Czechia1 site

  • II. interni klinika VFN - Kardiologie a angiologie

    Prague, 12808

Other trials in Czechia

Spain1 site

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

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 groups in NCT06260709
Study groupRoleWhat they receive
NNC6019-0001ExperimentalParticipants 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.

  1. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as events.

    Measured: From baseline (week 0) to up to 6 years

Secondary outcomes (6)

  1. Change in 6-Minute Walk Test (6MWT)

    Measured in meters.

    Measured: From baseline (week 0) to visit 28 (week 104)

  2. Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)

    Measured in percentage.

    Measured: From baseline (week 0) to visit 28 (week 104)

  3. Change in Myocardial Extracellular Volume (ECV)

    Measured in percentage-points.

    Measured: From baseline (week 0) to visit 28 (week 104)

  4. 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)

  5. Change in Troponin I

    Measured in nanogram per milliliter (ng/mL).

    Measured: From baseline (week 0) to visit 28 (week 104)

  6. 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.

  1. First posted15 Feb 2024
  2. Study start20 Feb 2024
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion9 Feb 2030 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Germany, Japan, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Adverse Events (TEAEs) (time frame: From baseline (week 0) to up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06260709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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