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

November 24, 2025 updated by: Novo Nordisk A/S

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 up to 157 weeks (36 months/3 years).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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-1
  • Germany
      • Heidelberg, Germany, 69120
        • Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
      • Heidelberg, Germany, 69120
        • UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
      • München, Germany, 81377
        • LMU Klinikum München Klinik und Poliklinik 1
      • Münster, Germany, 48149
        • Uniklinik Münster, Klinik für Kardiologie I
      • 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 CNR-Regione Toscana Gabriele Monasterio
      • 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
      • 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
      • 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.
      • Vila Real, Portugal, 5000-508
        • Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 90048
        • 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
      • Chicago, Illinois, United States, 60611
        • NW Univ-Bluhm Cardiovasc Inst
      • Evanston, Illinois, United States, 60208
        • NW Univ-Bluhm Cardiovasc Inst
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of MD Schl of Med
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NNC6019-0001
Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.
Drug: NNC6019-0001
Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment Emergent Adverse Events
Time Frame: From baseline (week 0) up to visit 39 (week 156)
Measured as events.
From baseline (week 0) up to visit 39 (week 156)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-Minute Walk Test (6MWT)
Time Frame: From baseline (week 0) to visit 28 (week 104)
Measured in meters.
From baseline (week 0) to visit 28 (week 104)
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Time Frame: From baseline (week 0) to visit 28 (week 104)
Measured in percentage.
From baseline (week 0) to visit 28 (week 104)
Change in Myocardial Extracellular Volume (ECV)
Time Frame: From baseline (week 0) to visit 28 (week 104)
Measured in percentage-points.
From baseline (week 0) to visit 28 (week 104)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
Time Frame: From baseline (week 0) to visit 28 (week 104)
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.
From baseline (week 0) to visit 28 (week 104)
Change in Troponin I
Time Frame: From baseline (week 0) to visit 28 (week 104)
Measured in nanogram per milliliter (ng/mL).
From baseline (week 0) to visit 28 (week 104)
Change in Global Longitudinal Strain (GLS) on Echocardiography
Time Frame: From baseline (week 0) to visit 28 (week 104)
Measured in percentage-points.
From baseline (week 0) to visit 28 (week 104)

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 (dept. 2834), Novo Nordisk A/S

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)

February 20, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

August 15, 2028

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN6019-7565
  • 2022-502605-15-00 (Other Identifier: European Medical Agency (EMA))
  • U1111-1284-5820 (Other Identifier: World Health Organization (WHO))
  • jRCT2071240078 (Registry Identifier: JRCT)

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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