At a glance
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A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 / VSA001 / SAR449124 Injection in Chinese Adults With Familial Chylomicronemia Syndrome
In Brief
A Phase 3 clinical trial evaluating Plozasiran and Placebon for Familial Chylomicronemia Syndrome. Completed, enrolled 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneous injection
Subcutaneous injection