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

Sponsor
Visirna Therapeutics HK Limited
Study ID
NCT05902598
Phase
PHASE3
Status
Completed

Conditions

  • Familial Chylomicronemia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Plozasiran — DRUG
    Subcutaneous injection
  • Placebon — DRUG
    Subcutaneous injection

Study Details

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.

Key Dates

Start date
Jul 10, 2023
Status verified
Mar 2025
Primary completion
Nov 26, 2024
Completion
Jan 9, 2026

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Plozasiran 25 mg
    Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months
  • Experimental: Plozasiran 50 mg
    Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months
  • Placebo Comparator: Placebo
    Matching placebo administered every 3 months for 12 months

Primary Outcome Measure

Percent Change From Baseline in Fasting Serum Triglyceride (TG) at Month 10 [ Time Frame: Baseline to Month 10 ]

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