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

Phase 2Active Not RecruitingNCT06260709

Novo Nordisk A/S80 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (35)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Cedars-Sinai Medical Center_Los Angeles

Los Angeles, California, United States

Stanford Hlth Cre-Boswell Clin

Stanford, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

NW Univ-Bluhm Cardiovasc Inst

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Treatment Emergent Adverse Events

Measured as events.

Time frame: From baseline (week 0) up to visit 39 (week 156)