Transthyretin Amyloid Cardiomyopathy Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu 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 (example [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.
Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
Body weight >120 kilogram (kg) (264.6 pounds [lb]) at screening.
History of contrast allergy or adverse reactions to gadolinium-containing agents.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

99

Study ID:

NCT05442047

Recruitment Status:

Recruiting

Sponsor:

Novo Nordisk A/S

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There are 29 Locations for this study

See Locations Near You

Novo Nordisk Investigational Site
Phoenix Arizona, 85054, United States
Novo Nordisk Investigational Site
Beverly Hills California, 90211, United States
Novo Nordisk Investigational Site
Stanford California, 94305, United States
Novo Nordisk Investigational Site
Jacksonville Florida, 32224, United States
Novo Nordisk Investigational Site
Evanston Illinois, 60208, United States
Novo Nordisk Investigational Site
Baltimore Maryland, 21201, United States
Novo Nordisk Investigational Site
Rochester Minnesota, 55905, United States
Novo Nordisk Investigational Site
Portland Oregon, 97239, United States
Novo Nordisk Investigational Site
Calgary Alberta, T2N 4, Canada
Novo Nordisk Investigational Site
Vancouver British Columbia, V5Z 1, Canada
Novo Nordisk Investigational Site
Praha 2 , 12808, Czechia
Novo Nordisk Investigational Site
Praha 2 , 12808, Czechia
Novo Nordisk Investigational Site
Créteil , 94010, France
Novo Nordisk Investigational Site
Toulouse Cedex 9 TSA 50032 , 31059, France
Novo Nordisk Investigational Site
Heidelberg , 69120, Germany
Novo Nordisk Investigational Site
München , 81377, Germany
Novo Nordisk Investigational Site
Münster , 48149, Germany
Novo Nordisk Investigational Site
Würzburg , 97078, Germany
Novo Nordisk Investigational Site
Pavia , 27100, Italy
Novo Nordisk Investigational Site
Fukuoka , 807-8, Japan
Novo Nordisk Investigational Site
Hiroshima , 734-8, Japan
Novo Nordisk Investigational Site
Kumamoto-shi, Kumamoto , 860-8, Japan
Novo Nordisk Investigational Site
Nagano , 390-8, Japan
Novo Nordisk Investigational Site
Nagasaki , 852-8, Japan
Novo Nordisk Investigational Site
Okayama-shi, Okayama , 700-8, Japan
Novo Nordisk Investigational Site
Groningen , 9713 , Netherlands
Novo Nordisk Investigational Site
Utrecht , 3584 , Netherlands
Novo Nordisk Investigational Site
Guimarães , 4835-, Portugal
Novo Nordisk Investigational Site
Vila Real , 5000-, Portugal
Novo Nordisk Investigational Site
Madrid , 28222, Spain

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

99

Study ID:

NCT05442047

Recruitment Status:

Recruiting

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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