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New hope for rare heart disease: experimental drug tested for long-term safety

NCT ID NCT06260709

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the long-term safety of an experimental drug called NNC6019-0001 in people with transthyretin amyloid cardiomyopathy, a rare heart disease that can lead to heart failure. All 80 participants have already completed an earlier study and will receive the drug every 4 weeks for up to 3 years. Researchers will monitor side effects and measure changes in walking ability, heart function, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NNC6019-0001
What this could lead to
If it works, this could point toward a treatment that reduces heart failure symptoms and improves daily function for people with this rare heart disease.
What could go wrong
This is a small, early-phase extension study with no placebo group, so results may not prove effectiveness. Long-term safety is still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloid cardiomyopathy (attr-CM)

Contacts and locations

Locations

  • Ap-Hp-Hopital Henri Mondor

    Créteil, 94000, France

  • Cedars-Sinai Medical Center_Los Angeles

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse, 31059, France

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

    Pavia, PV, 27100, Italy

  • Ctr for Cardiovascular Innovation

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Fondazione CNR-Regione Toscana Gabriele Monasterio

    Pisa, Pi, 56124, Italy

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

    Pisa, Pi, 56124, Italy

  • Hiroshima University hospital, Cardiovascular Medicine

    Hiroshima, 734-8551, Japan

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044, Portugal

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

    Fukuoka, 807-8556, Japan

  • II. interni klinika VFN - Kardiologie a angiologie

    Prague, 12808, Czechia

  • Kumamoto University Hospital, Cardiovascular Medicine

    Kumamoto-shi, Kumamoto, 860-8556, Japan

  • LMU Klinikum München Klinik und Poliklinik 1

    München, 81377, Germany

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • NW Univ-Bluhm Cardiovasc Inst

    Chicago, Illinois, 60611, United States

  • NW Univ-Bluhm Cardiovasc Inst

    Evanston, Illinois, 60208, United States

  • Nagasaki University Hospital, Cardiovascular Medicine

    Nagasaki, 852-8501, Japan

  • Okayama University Hospital_Cardiovascular Medicine

    Okayama-shi, Okayama, 700-8558, Japan

  • Shinshu University Hospital, Department of Neurology

    Nagano, 390-8621, Japan

  • Stanford Hlth Cre-Boswell Clin

    Stanford, California, 94305, United States

  • UMC Groningen

    Groningen, 9713 GZ, Netherlands

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

    Vila Real, 5000-508, Portugal

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

    Guimarães, 4835-044, Portugal

  • Uniklinik Münster, Klinik für Kardiologie I

    Münster, 48149, Germany

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

    Heidelberg, 69120, Germany

  • Univ of MD Schl of Med

    Baltimore, Maryland, 21201, United States

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitatsklinikum Wurzburg AöR

    Würzburg, 97078, Germany

  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

    Würzburg, 97078, Germany

  • University of Calgary_Cardiology

    Calgary, Alberta, T2N 4Z6, Canada

  • Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie

    Heidelberg, 69120, Germany

  • Universitätsklinikum Münster - Klinik für Kardiologie I

    Münster, 48149, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.