drugset / Trial / NCT06347016
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plozasiran | Small interfering RNA (siRNA) | — | Subcutaneous |
Indications
No indication recorded.