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

NCT05902598 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-02-27

Study results available
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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

DRUG

Plozasiran

Subcutaneous injection

DRUG

Placebon

Subcutaneous injection

Sponsors & Collaborators

  • Arrowhead Pharmaceuticals

    collaborator INDUSTRY

  • Visirna Therapeutics HK Limited

    lead INDUSTRY

Principal Investigators

  • Dong YOU, MD., PhD. · Visirna Therapeutics HK Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2024-11-26
Completion
2026-01-09
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05902598 on ClinicalTrials.gov