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

February 13, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary_Cardiology
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Ctr for Cardiovascular Innovation
  • Czechia
      • Prague, Czechia, 12808
        • II. interni klinika VFN - Kardiologie a angiologie
  • France
      • Créteil, France, 94000
        • Ap-Hp-Hopital Henri Mondor
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
      • Toulouse Cedex 9 TSA 50032, France, 31059
        • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
  • Germany
      • Heidelberg, Germany, 69120
        • UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
      • München, Germany, 81377
        • LMU Klinikum München Klinik und Poliklinik 1
      • Münster, Germany, 48149
        • Universitätsklinikum Münster - Klinik für Kardiologie I
      • Würzburg, Germany, 97078
        • Universitätsklinikum Würzburg AÖR
      • Würzburg, Germany, 97078
        • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
    • Pi
      • Pisa, Pi, Italy, 56124
        • Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare
  • Japan
      • Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
      • Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Hiroshima, Japan, 734-8551
        • Hiroshima University hospital, Cardiovascular Medicine
      • Hiroshima, Japan, 734-8551
        • Hiroshima University hospital_Cardiovascular Medicine
      • Kumamoto-shi, Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital, Cardiovascular Medicine
      • Nagano, Japan, 390-8621
        • Shinshu University Hospital, Department of Neurology
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital, Cardiovascular Medicine
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital_Cardiovascular Medicine
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen afdeling Cardiologie
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira - Guimarães
      • Guimarães, Portugal, 4835-044
        • Unidade Local de Saude do Alto Ave, E.P.E.
      • Guimarães, Portugal, 4835-044
        • ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
      • Vila Real, Portugal, 5000-508
        • ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real
  • Spain
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars-Sinai Medical Center_Los Angeles
      • Stanford, California, United States, 94305
        • Stanford Hlth Cre-Boswell Clin
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Illinois
      • Evanston, Illinois, United States, 60208
        • NW Univ-Bluhm Cardiovasc Inst
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
      • Baltimore, Maryland, United States, 21201
        • Univ of MD Schl of Med
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Oregon
      • Portland, Oregon, United States, 97239-4501
        • Oregon Hlth Sci Univ-Portland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.
Drug: Placebo (NNC6019-0001)
Participants will receive i.v. infusion of placebo (NNC6019-0001).
Experimental: NNC6019-0001, Dose 1
Participants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.
Drug: NNC6019-0001
Participants will receive i.v infusionof NNC6019-0001.
Experimental: NNC6019-0001, Dose 2
Participants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52.
Drug: NNC6019-0001
Participants will receive i.v infusionof NNC6019-0001.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute walk test (6-MWT)
Time Frame: From baseline (week 0) to visit 15 (week 52)
Measured in Meters
From baseline (week 0) to visit 15 (week 52)
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Time Frame: From baseline (week 0) to visit 15 (week 52)
Measured in Percentage
From baseline (week 0) to visit 15 (week 52)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in myocardial extracellular volume (ECV)
Time Frame: From baseline (week 0) to visit 15 (week 52)
Measured in Percentage (%)-points
From baseline (week 0) to visit 15 (week 52)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
Time Frame: From baseline (week 0) to visit 15 (week 52)
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.
From baseline (week 0) to visit 15 (week 52)
Change in neuropathy impairment score (NIS)
Time Frame: From baseline (week 0) to visit 15 (week 52)
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.
From baseline (week 0) to visit 15 (week 52)
Change in troponin I
Time Frame: From baseline (week 0) to visit 15 (week 52)
Measured in nanogram per milliliter (ng/mL)
From baseline (week 0) to visit 15 (week 52)
Change in global longitudinal strain (GLS) on echocardiography
Time Frame: From baseline (week 0) to visit 15 (week 52)
Measured in Percentage (%)-points
From baseline (week 0) to visit 15 (week 52)
Number of treatment emergent adverse events
Time Frame: From baseline (week 0) to visit 16 (week 64)
Measured as Events
From baseline (week 0) to visit 16 (week 64)
Time to occurrence of all-cause mortality
Time Frame: From baseline (week 0) to visit 16 (week 64)
Measured in Weeks
From baseline (week 0) to visit 16 (week 64)
Number of cardiovascular (CV) events comprising hospitalisation due to CV events or urgent heart failure visits
Time Frame: From baseline (week 0) to visit 16 (week 64)
Measured as Events
From baseline (week 0) to visit 16 (week 64)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency 2834, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

February 17, 2025

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN6019-4940
  • U1111-1271-3861 (Other Identifier: World Health Organization (WHO))
  • 2021-006226-49 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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