Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental drug shows promise for stiff heart disease

NCT ID NCT05442047

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called NNC6019-0001 in 105 people with transthyretin amyloid cardiomyopathy, a condition where abnormal proteins build up in the heart, causing heart failure. Participants received either the drug or a placebo by infusion every 4 weeks for about 64 weeks. The goal was to see if the drug could improve walking distance and reduce markers of heart strain.

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 (an experimental drug given by infusion)
What this could lead to
If it works, this could point toward a new treatment to manage heart failure symptoms in people with ATTR amyloid cardiomyopathy.
What could go wrong
This is an early Phase 2 trial with only 105 participants, so results may not apply to everyone. The drug is still experimental and not yet approved.

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

105 people

The number who actually took part.

Started

Aug 2022

Finished

May 2025

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: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Transthyretin amyloid cardiomyopathy (attr-CM) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    Beverly Hills, California, 90211, United States

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059, France

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse Cedex 9 TSA 50032, 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 Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare

    Pisa, Pi, 56124, Italy

  • Hiroshima University hospital, Cardiovascular Medicine

    Hiroshima, 734-8551, Japan

  • Hiroshima University hospital_Cardiovascular Medicine

    Hiroshima, 734-8551, Japan

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222, Spain

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044, Portugal

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, 807-8556, Japan

  • 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

    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

  • Oregon Hlth Sci Univ-Portland

    Portland, Oregon, 97239-4501, United States

  • Shinshu University Hospital, Department of Neurology

    Nagano, 390-8621, Japan

  • Stanford Hlth Cre-Boswell Clin

    Stanford, California, 94305, United States

  • ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real

    Vila Real, 5000-508, Portugal

  • ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães

    Guimarães, 4835-044, Portugal

  • UMC Groningen

    Groningen, 9713 GZ, Netherlands

  • UMC Groningen afdeling Cardiologie

    Groningen, 9713 GZ, Netherlands

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

    Guimarães, 4835-044, Portugal

  • 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

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

  • Universitätsklinikum Münster - Klinik für Kardiologie I

    Münster, 48149, Germany

More trials for these conditions

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