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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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Novo Nordisk

Record History

  1. Enrollment increased: 80 → 88 participants Site details revised at 1 of 38 sites Show 1 more changeShow less
    • Site details revised at 1 of 38 sites
  2. Primary endpoint(s) modified Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S · Trial sites expanded: 35 → 38 locations · Completion pushed from Aug 15, 2028 to Feb 9, 2030 · 2 more Show 5 more changesShow less
    • Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Trial sites expanded: 35 → 38 locations
    • Completion pushed from Aug 15, 2028 to Feb 9, 2030
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 6 entries
  3. Study sites: 33 to 35v21
  4. Study sites: 32 to 33v20
  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 50 to 32v19 Show 1 more changeShow less
    • Study sites: 50 to 32
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites revised (50)v18 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 2 of 50 sitesv17
  3. Site details revised at 6 of 50 sitesv16
  4. Site details revised at 3 of 50 sitesv15
  5. Study sites: 49 to 50v14
  6. Study sites: 46 to 49v13
  7. Study sites: 44 to 46v12
  8. Study sites: 39 to 44v11
  9. Site details revised at 1 of 39 sitesv10
  10. Study sites: 34 to 39v9
  11. Study sites: 33 to 34v8
  12. Study sites: 25 to 33 Completion date: Aug 28, 2028 to Aug 15, 2028v7 Show 1 more changeShow less
    • Completion date: Aug 28, 2028 to Aug 15, 2028
  13. Study sites: 23 to 25v6
  14. Completion date: Feb 29, 2028 to Aug 28, 2028 Site details revised at 1 of 23 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 23 sites
  15. Re-verified, no change to tracked fieldsv4
  16. Site details revised at 1 of 23 sitesv3
  17. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 9, 2024 to Feb 20, 2024 · Site details revised at 23 of 23 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 9, 2024 to Feb 20, 2024
    • Site details revised at 23 of 23 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
268 trials monitored
See 15 trials at risk
Amyloidosis
301 trials monitored
See 19 trials at risk
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 approximately 6 years or until NNC6019-0001 is commercially or otherwise available to the participant, whichever comes first.
Trial Details
NCT Number NCT06260709
Lead Sponsor Novo Nordisk A/S
Conditions Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov