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Clinical Trials in the USA / NCT05185843
Active, not recruiting Phase 3

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

NCT05185843 · tracked via the Priya Life Science USA tracker
Sponsor
Ionis Pharmaceuticals, Inc.
Phase
Phase 3
Started
2022-02-25
Last updated
2025-12-12

Condition(s) studied

Familial Chylomicronemia Syndrome

Investigational drug(s) / intervention(s)

Olezarsen

Olezarsen: Olezarsen will be administered by SC injection.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Diabetes/Lipid Management & Research Center Huntington Beach California
Excel Medical Clinical Trials, LLC Boca Raton Florida
University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND) Ann Arbor Michigan
University of Rochester School of Medicine Rochester New York
Centre for Heart Lung Innovation Vancouver British Columbia
ARC Biosystems, Clinical Assessment Unit (CAU) Vancouver British Columbia
St. Boniface General Hospital Winnipeg Manitoba
Ecogene-21 Chicoutimi Quebec
Clinique des Maladies Lipidiques de Quebec Inc. Québec Quebec
Centre Hospitalier Universite de Sherbrooke (CHUS) Sherbrooke Quebec
Karolinska University Hospital Huddinge Stockholm Sweden

More Ionis Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05185843 on ClinicalTrials.gov ↗ ← All trials in the USA