NCT06347003

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

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Plozasiran Injection	ARO-APOC3 Injection
DRUG	Placebo	sterile normal saline (0.9% NaCl)

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2024-04-04
• Last updated: 2025-10-27

Locations

196 sites across 17 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Hungary, Italy, Poland, Romania, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study