Status:
ACTIVE_NOT_RECRUITING
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Familial Chylomicronemia Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pre...
Detailed Description
This is a Phase 3, multi-center, open-label safety study in 24 participants with FCS, previously treated with volanesorsen. The study consists of an 8- week screening period, treatment period up to we...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Participants with FCS (clinical or genetic diagnosis) currently on or previously treated with volanesorsen (ISIS 304801)
- o Study participants in countries where Waylivra® is commercially approved and available for participants should not be deprived of the treatment option with Waylivra®. Participation in this study for such participants will only be allowed when Waylivra® was discontinued due to AEs
- The following concomitant medications will be allowed if dosing regimen is expected to remain constant through the end of the study (occasional or intermittent use of over-the-counter (OTC) medications will be allowed at Investigator's discretion):
- Statins, omega-3 fatty acids (prescription and OTC), fibrates, or other lipid-lowering medications. Participants taking OTC omega-3 fatty acids should make every effort to remain on the same brand through the end of the study
- Antidiabetic medications
- Oral anticoagulants (e.g., dabigatran, rivaroxaban, or apixaban, and warfarin with regular clinical monitoring)
- Tamoxifen, estrogens or progestins
- Key Exclusion Criteria:
- Treatment with another investigational drug (non-oligonucleotide), biological agent, or device within 4 weeks of Screening, or 5 half-lives of investigational agent, whichever is longer
- Concomitant medication/procedure restrictions:
- Systemic corticosteroids or anabolic steroids within 6 weeks prior to Screening and during the study unless approved by the Sponsor Medical Monitor
- Plasma apheresis within 4 weeks prior to Screening or planned during the study
Exclusion
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05185843
Start Date
February 25 2022
End Date
June 1 2027
Last Update
December 12 2025
Active Locations (11)
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1
Diabetes/Lipid Management & Research Center
Huntington Beach, California, United States, 92648
2
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States, 33434
3
University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND)
Ann Arbor, Michigan, United States, 48109-2800
4
University of Rochester School of Medicine
Rochester, New York, United States, 14642