AzTrials
AzTrials

Transthyretin Amyloid Cardiomyopathy (ATTR CM)Phase 2NCT05442047

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

A Phase 2 study testing NNC6019-0001 in people with Transthyretin Amyloid Cardiomyopathy (ATTR CM), run by Novo Nordisk A/S at 39 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. 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?
Yes, some participants may receive a placebo
How many people
105 participants
Where
39 sitesin 10 countries
Study dates
2 Aug 2022to 13 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
  • A prior solid organ transplant.
  • Planned solid organ transplant during the study.
  • 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.
  • 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.
  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
  • Body weight >120 kilogram (kg) (264.6 pounds [lb]) at screening.
  • History of contrast allergy or adverse reactions to gadolinium-containing agents.

Trial locations and contacts

39 sites in 10 countries.

39 sites in 10 countries

United States9 sites

  • Univ of MD Schl of Med

    Baltimore, Maryland, 21201

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Cedars-Sinai Medical Center_Los Angeles

    Beverly Hills, California, 90211

  • NW Univ-Bluhm Cardiovasc Inst

    Evanston, Illinois, 60208

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Oregon Hlth Sci Univ-Portland

    Portland, Oregon, 97239-4501

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Stanford Hlth Cre-Boswell Clin

    Stanford, California, 94305

Other trials in United States

Japan8 sites

  • Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology

    Fukuoka, 807-8556

  • Hospital of the University of Occupational and Environmental Health

    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-shi, Okayama, 700-8558

Other trials in Japan

Germany5 sites

  • UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie

    Heidelberg, 69120

  • LMU Klinikum München Klinik und Poliklinik 1

    München, 81377

  • Universitätsklinikum Münster - Klinik für Kardiologie I

    Münster, 48149

  • Universitatsklinikum Wurzburg AöR

    Würzburg, 97078

  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

    Würzburg, 97078

Other trials in Germany

Portugal4 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

  • Unidade Local de Saude do Alto Ave, E.P.E.

    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

France3 sites

  • Ap-Hp-Hopital Henri Mondor

    Créteil, 94000

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse Cedex 9 TSA 50032, 31059

Other trials in France

Netherlands3 sites

  • UMC Groningen afdeling Cardiologie

    Groningen, 9713 GZ

  • UMC Groningen

    Groningen, 9713 GZ

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Canada2 sites

  • University of Calgary_Cardiology

    Calgary, Alberta, T2N 4Z6

  • Ctr for Cardiovascular Innovation

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy2 sites

  • Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100

  • Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare

    Pisa, Pi, 56124

Other trials in Italy

Spain2 sites

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

Czechia1 site

  • II. interni klinika VFN - Kardiologie a angiologie

    Prague, 12808

Other trials in Czechia

About this study

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

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.

Being tested
NNC6019-0001, Placebo (NNC6019-0001)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC6019-0001Drug

    Participants will receive i.v infusionof NNC6019-0001.

  • Placebo (NNC6019-0001)Drug

    Participants will receive i.v. infusion of placebo (NNC6019-0001).

Study groups in NCT05442047
Study groupRoleWhat they receive
NNC6019-0001, Dose 1ExperimentalParticipants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.
Receives: Drug: NNC6019-0001
NNC6019-0001, Dose 2ExperimentalParticipants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52.
Receives: Drug: NNC6019-0001
PlaceboPlacebo comparatorParticipants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.
Receives: Drug: Placebo (NNC6019-0001)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6-minute walk test (6-MWT)

    Measured in Meters

    Measured: From baseline (week 0) to visit 15 (week 52)

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

    Measured in Percentage

    Measured: From baseline (week 0) to visit 15 (week 52)

Secondary outcomes (8)

  1. Change in myocardial extracellular volume (ECV)

    Measured in Percentage (%)-points

    Measured: From baseline (week 0) to visit 15 (week 52)

  2. 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: From baseline (week 0) to visit 15 (week 52)

  3. Change in neuropathy impairment score (NIS)

    NIS is a clinical assessment that tests muscle strength, reflex activity, and sensation of toes and fingers, and can be used to assess neurologic function in hereditary transthyretin amyloid (hATTR). The total NIS score is graded on a scale of 0-244, with a higher score indicating greater impairment.

    Measured: From baseline (week 0) to visit 15 (week 52)

  4. Change in troponin I

    Measured in nanogram per milliliter (ng/mL)

    Measured: From baseline (week 0) to visit 15 (week 52)

  5. Change in global longitudinal strain (GLS) on echocardiography

    Measured in Percentage (%)-points

    Measured: From baseline (week 0) to visit 15 (week 52)

  6. Number of treatment emergent adverse events

    Measured as Events

    Measured: From baseline (week 0) to visit 16 (week 64)

  7. Time to occurrence of all-cause mortality

    Measured in Weeks

    Measured: From baseline (week 0) to visit 16 (week 64)

  8. Number of cardiovascular (CV) events comprising hospitalisation due to CV events or urgent heart failure visits

    Measured as Events

    Measured: From baseline (week 0) to visit 16 (week 64)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start2 Aug 2022
  3. Primary completion17 Feb 2025
  4. Study completion13 May 2025

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442047
Sponsor's protocol ID
NN6019-4940
Other IDs
U1111-1271-3861, 2021-006226-49
Status last verified
Feb 2026
First submitted
28 Jun 2022
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Fontana M, Garcia-Pavia P, Grogan M, Shah SJ, Engelmann MDM, Hovingh GK, Kristen AV, Lim-Watson MZ, Malling B, Kar S, Revanna M, Sarswat N, Tsujita K, Alexander KM, Maurer MS. Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Circulation. 2026 Jan 27;153(4):214-225. doi: 10.1161/CIRCULATIONAHA.125.077304. Epub 2025 Nov 10.

    PubMed 41212997

  • Suhr OB, Grogan M, Silva AMD, Karam C, Garcia-Pavia P, Drachman B, Zago W, Tripuraneni R, Kinney GG. PRX004 in variant amyloid transthyretin (ATTRv) amyloidosis: results of a phase 1, open-label, dose-escalation study. Amyloid. 2025 Mar;32(1):14-21. doi: 10.1080/13506129.2024.2420809. Epub 2024 Oct 29.

    PubMed 39472768

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 39 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Japan, Germany, Portugal, France 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in 6-minute walk test (6-MWT) (time frame: From baseline (week 0) to visit 15 (week 52)). The study lists 2 primary outcomes in all. 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 NCT05442047, which also lists 2 linked publications.

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 17 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in