drugset / Trial / NCT06347016

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

NCT06347016 ↗

Phase 3 Active not recruiting 311 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
2024-07-23
Primary completion
2026-06
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.