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
NCT06260709 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-11-25
Summary
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)
Interventions
- DRUG
-
NNC6019-0001
Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-20
- Primary Completion
- 2028-02-29
- Completion
- 2028-08-15
- FDA Drug
- Yes
Countries
- United States
- Canada
- Czechia
- France
- Germany
- Italy
- Japan
- Netherlands
- Portugal
- Spain
Study Locations
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