Efficacy and Safety of NNC6019-0001 in ATTR CM

Summary

The purpose of this study is to determine whether an investigational drug called NNC6019-0001 can be used to treat people with transthyretin (TTR) amyloid cardiomyopathy, a heart disease due to TTR amyloidosis. Participants will undergo tests to check their heart (electrocardiograms, echocardiograms and magnetic resonance imaging), in addition to submitting blood samples and performing walking tests. Patients will also complete questionnaires about quality of life and health status. 

People with a heart disease due to TTR amyloidosis have changes in a specific protein circulating in the blood, called transthyretin. This changed protein can be detrimental, as it may increase the risk of heart failure or other complications. In previous studies of NNC6019-0001, a reduction in transthyretin was observed. In this study, participants will be randomly assigned to receive NNC6019-0001 or placebo. (They will have a 2:1 chance of getting the study drug.)

The information collected may also help researchers better understand heart disease due to TTR amyloidosis or related diseases; how the study drug works in the body; and how to improve the treatment of people with a heart disease due to TTR amyloidosis or related diseases.


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.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy

Details
Disease Type/Condition

Other

Principal Investigator

Patel, Jignesh

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002102

ClinicalTrials.gov ID

NCT05442047

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Patel, Jignesh

Age Group

Adult

Phase

N/A

IRB Number

NN6019-4940

ClinicalTrials.gov ID

NCT05442047

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?