A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
Running, not enrolling · Phase 3
Conditions studied: Familial Chylomicronemia Syndrome
In brief
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.
Key facts
- Study ID
- NCT05130450
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 60
- Starts
- 2021-11-18
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2025-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Diabetes/Lipid Management & Research Center — Huntington Beach, California, United States
- Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States
- Department of Pharmacy — Park Ridge, Illinois, United States
- University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
- CTSI Investigational Pharmacy — New York, New York, United States
- Milstein Hospital — New York, New York, United States
- IDS Central — Philadelphia, Pennsylvania, United States
- Ecogene-21 — Chicoutimi, Quebec, Canada
- Institute de Recherches Cliniques de Montreal — Montreal, Quebec, Canada
- Nathalie Saint-Pierre — Montreal, Quebec, Canada
- Clinique des Maladies Lipidiques de Quebec Inc. — Québec, Quebec, Canada
- 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, Netherlands
- 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
Full record on ClinicalTrials.gov
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