NCT06260709

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	NNC6019-0001	Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.

Timeline

• Start date: 2024-02-20
• Primary completion: 2028-02-29
• Completion: 2028-08-15
• First posted: 2024-02-15
• Last updated: 2025-11-25

Locations

35 sites across 10 countries: United States, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Portugal, Spain

Regulatory

• FDA-regulated drug study