drugset / Trial / NCT06347003

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

NCT06347003 ↗

Phase 3 Active not recruiting 446 enrolled Arrowhead Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-07-22
Primary completion
2026-06-12
Completion
2026-09

Outcome

Met primary endpoint

release “SHASTA-3 and SHASTA-4 successfully met the primary endpoint of triglyceride reduction versus placebo and met all prespecified secondary endpoints in both studies” arrowheadpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Plozasiran Small interfering RNA (siRNA) — Subcutaneous

Indications

No indication recorded.