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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

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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)

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

Trial contacts and locations

25

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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