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

Last updated: February 27, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Circulation Disorders

Amyloidosis

Treatment

NNC6019-0001

Clinical Study ID

NCT06260709
NN6019-7565
U1111-1284-5820
jRCT2071240078
2022-502605-15-00
  • Ages 18-85
  • All Genders

Study 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. 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).

Eligibility Criteria

Inclusion

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 tothe enrolment visit.

Exclusion

Exclusion Criteria:

  • A prior solid organ transplant.

  • Presence or history of malignant neoplasm (other than basal or squamous cell skincancer, in-situ carcinomas of the cervix, or in-situ/high grade prostaticintraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years beforescreening.

  • Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers isallowed. The use of digoxin will only be allowed if required for management ofatrial fibrillation with rapid ventricular response.

  • Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: NNC6019-0001
Phase: 2
Study Start date:
February 20, 2024
Estimated Completion Date:
August 15, 2028

Connect with a study center

  • University of Calgary_Cardiology

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • Ctr for Cardiovascular Innovation

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • II. interni klinika VFN - Kardiologie a angiologie

    Praha 2, 12808
    Czechia

    Site Not Available

  • Ap-Hp-Hopital Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • LMU Klinikum München Klinik und Poliklinik 1

    München, 81377
    Germany

    Site Not Available

  • Uniklinik Münster, Klinik für Kardiologie I

    Münster, 48149
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg AöR

    Würzburg, 97078
    Germany

    Site Not Available

  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

    Würzburg, 97078
    Germany

    Active - Recruiting

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

    Pavia, PV 27100
    Italy

    Site Not Available

  • Fondazione CNR-Regione Toscana Gabriele Monasterio

    Pisa, Pi 56124
    Italy

    Active - Recruiting

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

    Fukuoka, 807-8556
    Japan

    Active - Recruiting

  • Hiroshima University hospital, Cardiovascular Medicine

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • Kumamoto University Hospital, Cardiovascular Medicine

    Kumamoto-shi, Kumamoto, 860-8556
    Japan

    Active - Recruiting

  • Shinshu University Hospital, Department of Neurology

    Nagano, 390-8621
    Japan

    Site Not Available

  • Nagasaki University Hospital, Cardiovascular Medicine

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Okayama University Hospital_Cardiovascular Medicine

    Okayama-shi, Okayama, 700-8558
    Japan

    Site Not Available

  • UMC Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044
    Portugal

    Site Not Available

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

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Centro Hospitalar de Trás-os-Montes e Alto Douro

    Vila Real, 5000-508
    Portugal

    Site Not Available

  • Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.

    Vila Real, 5000-508
    Portugal

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Cedars-Sinai Medical Center_Los Angeles

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Cedars-Sinai Medical Center_Los Angeles

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford Hlth Cre-Boswell Clin

    Stanford, California 94305
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • NW Univ-Bluhm Cardiovasc Inst

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • NW Univ-Bluhm Cardiovasc Inst

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Univ of MD Schl of Med

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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