Overview

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

Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Criteria
Inclusion Criteria

1. 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

2. 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

Exclusion Criteria:

1. 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

2. Concomitant medication/procedure restrictions:

1. Systemic corticosteroids or anabolic steroids within 6 weeks prior to Screening
and during the study unless approved by the Sponsor Medical Monitor

2. Plasma apheresis within 4 weeks prior to Screening or planned during the study