A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

NCT05130450 · tracked via the Priya Life Science USA tracker

Sponsor

Ionis Pharmaceuticals, Inc.

Phase

Phase 3

Started

2021-11-18

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 this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: • Satisfactory completion of treatment with olezarsen in the index study (ISIS 678354-CS3, last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement. Exclusion Criteria: • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (ISIS 678354-CS3).

Primary outcome measure(s)

Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline — Baseline and 6 months

Trial sites (27)

Facility	City	Region
Diabetes/Lipid Management & Research Center	Huntington Beach	California
Excel Medical Clinical Trials, LLC	Boca Raton	Florida
Department of Pharmacy	Park Ridge	Illinois
University of Kansas Medical Center (KUMC)	Kansas City	Kansas
CTSI Investigational Pharmacy	New York	New York
Milstein Hospital	New York	New York
IDS Central	Philadelphia	Pennsylvania
Ecogene-21	Chicoutimi	Quebec
Institute de Recherches Cliniques de Montreal	Montreal	Quebec
Nathalie Saint-Pierre	Montreal	Quebec
Clinique des Maladies Lipidiques de Quebec Inc.	Québec	Quebec
Groupement Hospitalier Est- Pharmacie Secteur Essais Clinique	Bron	France
Hôpital Bicêtre	Le Kremlin-Bicêtre	France
Pharmacie Hopital de la Conception	Marseille	France
Via Sergio Pansini 5	Naples	Italy
UOC di Farmacia AOUP PAOLO GIACCONE	Palermo	Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I	Rome	Italy
Academisch Medisch Centrum Goederenontvangst Apotheek t.a.v. Kenniscentrum	Amsterdam	Noor-Holland
Oslo Hospital Pharmacy Rikshospitalet	Oslo	Norway
Hospital da Senhora da Oliveira Guimaraes	Creixomil	Portugal
Dra Margarida Falcao Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz	Lisbon	Portugal
Metabolicke centrum MU	Bratislava	Slovakia
Hospital Clínic Barcelona C/ Villarroel	Barcelona	Spain
Hospital Universitario 12 de Octubre	Madrid	Spain
Hospital Universitario Virgen del Rocío	Seville	Spain
Apokteket AB	Malmö	Sweden
Royal Manchester Children's Hospital	Manchester	United Kingdom

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Other trials for the same condition

A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants Recruiting

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects 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 Active, not recruiting

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 NCT05130450 on ClinicalTrials.gov ↗ ← All trials in the USA