A Research Study to Look at How a New Medicine Called NNC... | NCT05442047

NCT05442047

ID	Type	Description	Link
U1111-1271-3861	Other Identifier	World Health Organization (WHO)
2021-006226-49	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC6019-0001, Dose 1	Experimental	Participants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.	Drug: NNC6019-0001
NNC6019-0001, Dose 2	Experimental	Participants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52.	Drug: NNC6019-0001
Placebo	Placebo Comparator	Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.	Drug: Placebo (NNC6019-0001)

Name	Type	Description	Arm Group Labels	Other Names
NNC6019-0001	Drug	Participants will receive i.v infusionof NNC6019-0001.	NNC6019-0001, Dose 1 NNC6019-0001, Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in 6-minute walk test (6-MWT)	Measured in Meters	From baseline (week 0) to visit 15 (week 52)
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)	Measured in Percentage	From baseline (week 0) to visit 15 (week 52)

Secondary Outcomes

Measure	Description	Time Frame
Change in myocardial extracellular volume (ECV)	Measured in Percentage (%)-points	From baseline (week 0) to visit 15 (week 52)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)

Eligibility Module

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.

Name	Affiliation	Role
Clinical Transparency 2834	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Phoenix	Arizona	85054	United States
Cedars-Sinai Medical Center_Los Angeles

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41212997	Derived	Fontana M, Garcia-Pavia P, Grogan M, Shah SJ, Engelmann MDM, Hovingh GK, Kristen AV, Lim-Watson MZ, Malling B, Kar S, Revanna M, Sarswat N, Tsujita K, Alexander KM, Maurer MS. Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Circulation. 2026 Jan 27;153(4):214-225. doi: 10.1161/CIRCULATIONAHA.125.077304. Epub 2025 Nov 10.
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The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.