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Clinical Trials in Italy / NCT05130450
Active, not recruiting Phase 3

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

NCT05130450 · tracked via the Priya Life Science Italy 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
No
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)

FacilityCityRegionStatus
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

More Ionis Pharmaceuticals, Inc. trials in Italy

PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717 Active, not recruiting
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) Enrolling by invitation
REVEAL: A Phase 3 Study of Obudanersen (ION582) in Angelman Syndrome Active, not recruiting
A Study to Evaluate the Safety and Efficacy of Zilganersen (ION373) in Patients With Alexander Disease (AxD) Active, not recruiting
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) 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 Italy