Long-Term Safety and Efficacy of NNC6019-0001 in Transthretin Amyloid Cardiomyopathy

What is the Purpose of this Study?

The purpose of this study is to evaluate the long-term safety and effectiveness of a medicine called NNC6019-0001 in people who have heart failure due to transthyretin (TTR) amyloidosis (build-up of abnormal protein in heart cells). People with heart disease due to TTR protein build-up have changes in a specific protein circulating in the blood, called transthyretin. This changed protein can be harmful, as it can make the risk of heart failure or other complications higher. Previous studies show that NNC6019-0001 may be helpful in treating people with heart failure due to TTR amyloidosis. Procedures include electrocardiograms, echocardiograms, and magnetic resonance imaging, blood samples, walking tests, and questionnaires about quality of life and health status. Researchers also hope to better understand how NNC6019-0001 works in the body, as well as how to improve the treatment of people with a heart disease due to TTR protein build up or related diseases. This study is an extension of a prior study investigating NNC6019-0001; only participants who have completed that study are eligible for this one. All participants in this study will receive NNC6019-0001, regardless of whether they received NNC6019-0001 or placebo (inactive substance) in the first study.


Eligibility

  • * 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.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Open-label extension study of long-term safety and efficacy of NNC6019-0001 in participants with transthyretin amyloid cardiomyopathy

Study Details
Disease Type/Condition

Other

Principal Investigator

Cole, Robert

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00003513

ClinicalTrials.gov ID

NCT06260709

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Cole, Robert

Age Group

Adult

Phase

Not Available

IRB Number

NN6019-7565

ClinicalTrials.gov ID

NCT06260709

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org