NCT05442047

A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.

Conditions

• Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Interventions

Type	Name	Description
DRUG	NNC6019-0001	Participants will receive i.v infusionof NNC6019-0001.
DRUG	Placebo (NNC6019-0001)	Participants will receive i.v. infusion of placebo (NNC6019-0001).

Timeline

• Start date: 2022-08-02
• Primary completion: 2025-02-17
• Completion: 2025-05-13
• First posted: 2022-07-01
• Last updated: 2026-02-17

Locations

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

Regulatory

• FDA-regulated drug study