Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06347016 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Study acronym: SHASTA-4
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Sep 2026 to Sep 10, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 19 entries
  2. Primary completion date changed from estimate of Jun 2026 to Jun 17, 2026
    • Site details revised at 1 of 149 sites
    v23
  3. Secondary endpoints revised (19)v22
  4. Study sites: 148 to 149v21
  5. Primary endpoint revisedv20 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 311
    • Study sites: 149 to 148
    • Primary completion date: Jul 2026 to Jun 2026
    • Study completion date: Oct 2026 to Sep 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 17 to 19
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 148 to 149v19
  2. Study sites: 124 to 148v18
  3. Study sites: 81 to 124v17
  4. Study sites: 80 to 81v16
  5. Study sites: 51 to 80v15
  6. Study sites: 47 to 51v14
  7. Study sites: 40 to 47v13
  8. Study sites: 36 to 40v12
  9. Study sites: 31 to 36v11
  10. Study sites: 14 to 31v10
  11. Start date changed from estimate of Jul 2024 to Jul 23, 2024v9
  12. Start date: Jun 2024 to Jul 2024v8
  13. Study sites: 13 to 14v7
  14. Study sites: 9 to 13
    • Start date: May 2024 to Jun 2024
    v6
  15. Study sites: 3 to 9v5
  16. Study sites: 1 to 3v4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  18. Study title shortened, about 1 wordv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.
Trial Details
NCT Number NCT06347016
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Severe Hypertriglyceridemia
Related terms Hypertriglyceridemia
Enrollment 311 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov