NCT05902598

A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome

A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 / VSA001 / SAR449124 Injection in Chinese Adults With Familial Chylomicronemia Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Visirna Therapeutics HK Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blinded, placebo controlled, two periods phase 3 clinical study. The primary objective of the study was to evaluate the efficacy and safety of Plozasiran injection in Chinese adults with familial chylomicronemia syndrome (FCS). A total of 37 participants were enrolled in the study. The duration of the study randomized period was approximately 112 weeks, including a screening period of up to 8 weeks and a treatment period of up to 104 weeks. Participants who completed the randomized period will continue in a 1-year open-label extension period where all participants will receive Plozasiran.

Conditions

• Familial Chylomicronemia Syndrome

Interventions

Type	Name	Description
DRUG	Plozasiran	Subcutaneous injection
DRUG	Placebon	Subcutaneous injection

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-11-26
• Completion: 2026-01-09
• First posted: 2023-06-15
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study