Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05185843 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

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

Record History

  1. Re-verified, no change to tracked fieldsv15
  2. Primary completion date: Mar 2025 to Jun 2027 Completion date: Jun 2025 to Jun 2027 · Secondary endpoints: details revised at 14 of 14 entries · Study description expanded, about 23 words · 1 morev14 Show 4 more changesShow less
    • Completion date: Jun 2025 to Jun 2027
    • Secondary endpoints: details revised at 14 of 14 entries
    • Study description expanded, about 23 words
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoints revised (7) Study description shortened, about 17 wordsv13 Show 1 more changeShow less
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv12
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 30 to confirmed 24 · Site details revised at 11 of 11 sitesv11 Show 2 more changesShow less
    • Enrollment target: estimated 30 to confirmed 24
    • Site details revised at 11 of 11 sites
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Nov 2023 to Mar 2025 Primary endpoints revised (7) · Completion date: Feb 2024 to Jun 2025 · Secondary endpoints: 25 to 14 · 1 morev10 Show 4 more changesShow less
    • Primary endpoints revised (7)
    • Completion date: Feb 2024 to Jun 2025
    • Secondary endpoints: 25 to 14
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Dec 2024 to Nov 2023 Completion date: Mar 2025 to Feb 2024v9 Show 1 more changeShow less
    • Completion date: Mar 2025 to Feb 2024
  3. Study sites: 9 to 11v8
  4. Study sites: 7 to 9v7
  5. Study sites: 6 to 7v6
  6. Study sites: 5 to 6v5
  7. Study sites: 3 to 5v4
  8. Re-verified, no change to tracked fieldsv3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Jan 2022 to Feb 25, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 2022 to Feb 25, 2022
  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.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.
Trial Details
NCT Number NCT05185843
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Familial Chylomicronemia Syndrome
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov