A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis

Novo Nordisk

Status and phase: Enrolling; Phase 2

Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Treatments: Drug: NNC6019-0001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06260709

NN6019-7565

2022-502605-15-00 (Other Identifier)

U1111-1284-5820 (Other Identifier)

Details and patient eligibility

About

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
• Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Exclusion criteria

• A prior solid organ transplant.
• Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ 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 (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.
• Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

NNC6019-0001

Experimental group

Description:

Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.

Treatment:

Drug: NNC6019-0001