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A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5 Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 3 of 36 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 3 of 36 entries
    • Study description revised
  2. Eligibility criteria shortened, about 24 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 3 to 4 Start date changed from estimate of Jul 2026 to Jul 31, 2026 · Secondary endpoints: details revised at 4 of 36 entriesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2026 to Jul 31, 2026
    • Secondary endpoints: details revised at 4 of 36 entries
  4. Study sites: 1 to 3v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary purpose of the study is to evaluate the efficacy of olezarsen administered by subcutaneous injection to pediatric participants with FCS.
Trial Details
NCT Number NCT07727538
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Familial Chylomicronemia Syndrome
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov