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NCT Number: NCT06260709

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary_Cardiology, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC6019-0001

Drug

Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.

Primary outcomes

  1. Number of Treatment Emergent Adverse Events

    Time frame: From baseline (week 0) up to visit 39 (week 156)

    Measured as events.

Secondary outcomes

  1. Change in 6-Minute Walk Test (6MWT)

    Time frame: From baseline (week 0) to visit 28 (week 104)

    Measured in meters.

  2. Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)

    Time frame: From baseline (week 0) to visit 28 (week 104)

    Measured in percentage.

  3. Change in Myocardial Extracellular Volume (ECV)

    Time frame: From baseline (week 0) to visit 28 (week 104)

    Measured in percentage-points.

  4. 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.

  5. Change in Troponin I

    Time frame: From baseline (week 0) to visit 28 (week 104)

    Measured in nanogram per milliliter (ng/mL).

  6. Change in Global Longitudinal Strain (GLS) on Echocardiography

    Time frame: From baseline (week 0) to visit 28 (week 104)

    Measured in percentage-points.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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