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Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Study acronym: SHASTA-3
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 Aug 25, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 20 entries
  2. Primary completion date changed from estimate of Jun 2026 to Jun 12, 2026
    • Site details revised at 10 of 196 sites
    v22
  3. Secondary endpoints revised (20)v21
  4. Study sites revised (196)v20
  5. Trial status: Recruiting to Active, Not Recruitingv19 Show 6 more changesShow less
    • Enrollment target: estimated 405 to confirmed 446
    • Primary completion date: Jul 2026 to Jun 2026
    • Study completion date: Oct 2026 to Sep 2026
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: 17 to 20
    • Site details revised at 196 of 196 sites
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 162 to 196v18
  2. Study sites: 92 to 162v17
  3. Study sites: 51 to 92v16
  4. Study sites: 46 to 51v15
  5. Study sites: 41 to 46v14
  6. Study sites: 39 to 41v13
  7. Study sites: 33 to 39v12
  8. Study sites: 31 to 33v11
  9. Study sites: 17 to 31v10
  10. Start date changed from estimate of Jul 2024 to Jul 22, 2024v9
  11. Start date: Jun 2024 to Jul 2024v8
  12. Study sites: 15 to 17v7
  13. Study sites: 10 to 15
    • Start date: May 2024 to Jun 2024
    v6
  14. Study sites: 7 to 10v5
  15. Study sites: 3 to 7v4
  16. Study sites: 1 to 3v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study title shortened, about 1 word
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT06347003
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Severe Hypertriglyceridemia
Related terms Hypertriglyceridemia
Enrollment 446 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov