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CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

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

Record History

The 50 most recent of 65 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 800 to confirmed 885 · Site details revised at 262 of 262 sitesv65 Show 2 more changesShow less
    • Enrollment target: estimated 800 to confirmed 885
    • Site details revised at 262 of 262 sites
  2. Study sites: 255 to 262v64
  3. Study sites: 251 to 255v63
  4. Primary completion date: May 2026 to Mar 2027 Primary endpoints revised (3) · Study sites: 222 to 251 · Completion date: Sep 2026 to Mar 2027 · 2 morev62 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 222 to 251
    • Completion date: Sep 2026 to Mar 2027
    • Eligibility criteria expanded, about 154 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 220 to 222v61
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 217 to 220v60
  2. Study sites: 207 to 217v59
  3. Study sites: 205 to 207v58
  4. Study sites: 190 to 205v57
  5. Study sites: 187 to 190v56
  6. Study sites: 181 to 187v55
  7. Study sites: 179 to 181v54
  8. Study sites: 176 to 179v53
  9. Enrollment target: 700 to 800 Eligibility criteria expanded, about 14 words · Study description revised · Study title expanded, about 1 wordv52 Show 3 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Study description revised
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 175 to 176v51
  11. Study sites: 173 to 175v50
  12. Study sites: 170 to 173v49
  13. Study sites: 167 to 170v48
  14. Study sites: 155 to 167v47
  15. Study sites: 136 to 155v46
  16. Study sites: 128 to 136v45
  17. Study sites: 116 to 128v44
  18. Study sites: 112 to 116v43
  19. Study sites: 109 to 112v42
  20. Study sites: 107 to 109v41
  21. Study sites: 104 to 107v40
  22. Study sites: 102 to 104v39
  23. Study sites: 97 to 102v38
  24. Study sites: 90 to 97v37
  25. Study sites: 84 to 90v36
  26. Re-verified, no change to tracked fieldsv35
  27. Study sites: 78 to 84v34
  28. Study sites: 77 to 78v33
  29. Study sites: 75 to 77v32
  30. Study sites: 74 to 75v31
  31. Study sites: 72 to 74v30
  32. Study sites: 68 to 72v29
  33. Study sites: 65 to 68v28
  34. Study sites: 61 to 65v27
  35. Study sites: 59 to 61v26
  36. Study sites: 57 to 59v25
  37. Study sites: 50 to 57v24
  38. Study sites: 45 to 50v23
  39. Study sites: 44 to 45v22
  40. Study sites: 39 to 44v21
  41. Study sites: 37 to 39v20
  42. Study sites: 36 to 37v19
  43. Study sites: 22 to 36v18
  44. Study sites: 20 to 22v17
  45. Study sites: 18 to 20v16
  • 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 safety and tolerability of olezarsen in participants with SHTG.
Trial Details
NCT Number NCT05681351
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Severe Hypertriglyceridemia
Enrollment 885 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov