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
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
ClinicalTrials.gov ID: NCT05442047
Sponsor: Novo Nordisk A/S
Information provided by: Novo Nordisk A/S (Responsible Party)
Last Update Posted: 2023-10-19
Brief 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.
Official Title:
Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Intervention / Treatment:
- Drug: NNC6019-0001
- Drug: Placebo (NNC6019-0001)
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-08-02 |
| Primary Completion (Estimated) |
2024-05-07
|
| Study Completion (Estimated) | 2025-02-17 |
| Enrollment (Estimated) | 99 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
NN6019-4940 |