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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260709 on ClinicalTrials.gov