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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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