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

Description

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).

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

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Study Overview

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Study Details

Study overview

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).

Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

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

Condition
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Los Angeles

Cedars-Sinai Medical Center_Los Angeles, Los Angeles, California, United States, 90048

Stanford

Stanford Hlth Cre-Boswell Clin, Stanford, California, United States, 94305

Jacksonville

Mayo Clinic Jacksonville, Jacksonville, Florida, United States, 32224

Chicago

NW Univ-Bluhm Cardiovasc Inst, Chicago, Illinois, United States, 60611

Evanston

NW Univ-Bluhm Cardiovasc Inst, Evanston, Illinois, United States, 60208

Baltimore

Univ of MD Schl of Med, Baltimore, Maryland, United States, 21201

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2028-08-15