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Long-term treatment for heart failure due to TTR amyloidosis

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

Phase 2 Interventional Novo Nordisk A/S · NCT06260709

This study is testing a medication called NNC6019-0001 to see if it can help people with heart failure caused by transthyretin amyloidosis feel better over a long period of time.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations50 sites (Phoenix, Arizona and 49 other locations)
Trial IDNCT06260709 on ClinicalTrials.gov

What this trial studies

This study will evaluate the long-term safety and efficacy of a medication called NNC6019-0001 in patients with heart failure caused by transthyretin amyloidosis. Participants must have previously completed a related study and will receive NNC6019-0001 for up to 157 weeks, regardless of their previous treatment. The goal is to determine if this medication can alleviate symptoms associated with this heart condition. The study is designed to provide insights into the long-term management of this rare form of heart disease.

Who should consider this trial

Good fit: Ideal candidates are individuals who have completed a prior study involving NNC6019-0001 and are on stable cardiovascular therapy.

Not a fit: Patients with a history of solid organ transplants or certain malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from heart failure due to TTR amyloidosis.

How similar studies have performed: Other studies have shown promise in treating transthyretin amyloidosis, but this specific approach is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Transthyretin Amyloid Cardiomyopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.