Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This is a Phase 3, multi-center, open-label safety study of up to 30 participants with FCS, previously treated with volanesorsen. The study consists of 3 periods: 1) Screening Period: Week -4 to Week -1 (up to 4 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen every 4 weeks during the 53-week Treatment Period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05185843
Study type Interventional
Source Ionis Pharmaceuticals, Inc.
Contact Ionis Pharmaceuticals
Phone 800-679-4747
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date January 2022
Completion date March 2025

See also
  Status Clinical Trial Phase
Completed NCT04223908 - InFocus France Epidemiological Study of Health Burden in Major Hypertriglyceridemia
Recruiting NCT05130450 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) Phase 3
Recruiting NCT04568434 - A Study of AKCEA-APOCIII-LRx Administered to Patients With Familial Chylomicronemia Syndrome (FCS) Phase 3
Completed NCT03912181 - Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes
Completed NCT02658175 - The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome Phase 3
Completed NCT03360747 - Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS) Phase 2
Completed NCT02211209 - The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome Phase 3