Clinical Trial

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2021-12-22; most recent amendment 2025-12-05.
Status change: Recruiting → Active, Not Recruiting 2023-08-07
Status change: Not Yet Recruiting → Recruiting 2022-03-09
Trial Details
NCT Number NCT05185843
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Familial Chylomicronemia Syndrome
Enrollment 24 participants
Start Date 2022-02-25
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-12