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A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv33
  2. Notable Primary completion date: Jan 2025 to Feb 2028 Completion date: Apr 2025 to Feb 2028v32 Show 1 more changeShow less
    • Completion date: Apr 2025 to Feb 2028
  3. Minor 3 versions Re-verified since May 9, 2024, no change to tracked fieldsv29-v31
  4. Minor Secondary endpoints: 13 to 18v28 See this version in full on ClinicalTrials.gov ↗
  5. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 27 of 27 sitesv27 Show 1 more changeShow less
    • Site details revised at 27 of 27 sites
Show 25 earlier versionsHide 25 earlier versions
  1. Minor Study sites: 26 to 27v26
  2. Minor Secondary endpoints revised (13) Study description expanded, about 29 wordsv25 Show 1 more changeShow less
    • Study description expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 25 to 26v24
  4. Minor Study sites: 22 to 25v23
  5. Minor Study sites: 21 to 22v22
  6. Minor Study sites: 20 to 21v21
  7. Minor Study sites: 19 to 20v20
  8. Minor Study sites: 17 to 19v19
  9. Minor Study sites: 16 to 17v18
  10. Minor Study sites: 15 to 16v17
  11. Minor Study sites: 14 to 15v16
  12. Minor Study sites: 13 to 14v15
  13. Minor Study sites: 12 to 13v14
  14. Minor Study sites: 10 to 12v13
  15. Minor Study sites: 9 to 10v12
  16. Minor Study sites: 8 to 9v11
  17. Minor Study sites: 7 to 8v10
  18. Minor Study sites: 6 to 7v9
  19. Minor Study sites: 5 to 6v8
  20. Minor Primary completion date: Dec 2024 to Jan 2025 Completion date: Mar 2025 to Apr 2025 · Start date: Nov 19, 2021 to Nov 18, 2021v7 Show 2 more changesShow less
    • Completion date: Mar 2025 to Apr 2025
    • Start date: Nov 19, 2021 to Nov 18, 2021
  21. Minor Study sites: 4 to 5v6
  22. Minor Study sites: 3 to 4v5
  23. Minor Study sites: 1 to 3v4
  24. Minor Re-verified, no change to tracked fieldsv3
  25. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2021 to Nov 19, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2021 to Nov 19, 2021
  1. Minor 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.
The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.
Trial Details
NCT Number NCT05130450
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Familial Chylomicronemia Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov