NNC6019-0001 for Transthyretin Amyloid Cardiomyopathy
Trial Summary
What is the purpose of this trial?
This trial is testing a new medicine, NNC6019-0001, for people with heart disease due to TTR amyloidosis. Participants will receive the medicine by chance, with a higher likelihood of getting the medicine. The goal is to see if it can reduce heart disease symptoms over a period of time.
Research Team
Clinical Transparency 2834
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
This trial is for adults aged 18-85 with heart disease due to TTR amyloidosis, classified as NYHA Class II-III. They must have a specific diagnosis of ATTR CM, be on stable heart medication for 6 weeks prior, and meet certain lab test criteria. Exclusions include recent major cardiovascular events or surgeries, planned organ transplants, other types of cardiomyopathy, cancer history within 5 years, contrast allergies, and weight over 120 kg.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- NNC6019-0001 (Unknown)
- Placebo (NNC6019-0001) (Unknown)
NNC6019-0001 is already approved in Japan for the following indications:
- Transthyretin amyloid cardiomyopathy (ATTR-CM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen