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Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

Study acronym: SHASTA-5
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 121 → 140 locations
    • Secondary endpoints: details revised at 2 of 8 entries
    • Eligibility criteria shortened, about 2 words
  2. Trial sites expanded: 102 → 121 locationsv10
  3. Trial sites expanded: 95 → 102 locationsv9
  4. Trial sites expanded: 91 → 95 locationsv8
  5. Trial sites expanded: 83 → 91 locationsv7
  6. Trial sites expanded: 61 → 83 locationsv6
  7. Study sites: 33 to 61v5
  8. Study sites: 20 to 33v4
  9. Enrollment target: 140 to 288
    • Study sites: 7 to 20
    • Secondary endpoints revised (8)
    • Eligibility criteria shortened, about 4 words
    v3
  10. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Mar 2028 to Mar 2029
    • Study sites: 0 to 7
    • Start date changed from estimate of Apr 2025 to Apr 24, 2025
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints revised (8)
  11. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
Trial Details
NCT Number NCT06880770
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Severe Hypertriglyceridemia
Related terms Hypertriglyceridemia
Enrollment 288 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov