Clinical Trial

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Study acronym: SHASTA-4
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2024-03-29; most recent amendment 2025-10-23.
Status change: Recruiting → Active, Not Recruiting 2025-07-18
Status change: Not Yet Recruiting → Recruiting 2024-04-27
Trial Details
NCT Number NCT06347016
Lead Sponsor Arrowhead Pharmaceuticals
Conditions Severe Hypertriglyceridemia
Enrollment 311 participants
Start Date 2024-07-23
Primary Completion 2026-06-17 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-06