A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for P… (NCT05442047) | Clinical Trial Compass
CompletedPhase 2
A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis
United States105 participantsStarted 2022-08-02
Plain-language summary
This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.
* Known end-diastolic interventricular septal wall thickness greater than or equal to (\>=) 12 millimeters (mm).
* Presently classified as New York Heart Association (NYHA) Class II-III.
* N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or equal to (\>=) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater than (\>) 1000 pg/mL in atrial fibrillation at screening.
* Completed greater than or equal to (\>=) 150 meters to less than or equal to (\<=) 450 meters on the 6-minute walk test (MWT) at screening.
* Estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at screening.
Exclusion Criteria:
* Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy transthyretin amyloid cardiomyopathy (ATTR CM), for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
* A prior solid organ transplant.
* Planned solid organ transplant during the study.
* Pr…
What they're measuring
1
Change in 6-minute walk test (6-MWT)
Timeframe: From baseline (week 0) to visit 15 (week 52)
2
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Timeframe: From baseline (week 0) to visit 15 (week 52)