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ACTIVE NOT RECRUITING Phase 3

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

NCT05130450 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Olezarsen

Study Locations (20)

Other

  • Groupement Hospitalier Est- Pharmacie Secteur Essais Clinique — Bron
  • Hôpital Bicêtre — Le Kremlin-Bicêtre
  • Pharmacie Hopital de la Conception — Marseille
  • Via Sergio Pansini 5 — Naples
  • UOC di Farmacia AOUP PAOLO GIACCONE — Palermo
  • Azienda Ospedaliero Universitaria Policlinico Umberto I — Rome
  • Oslo Hospital Pharmacy Rikshospitalet — Oslo
  • Hospital da Senhora da Oliveira Guimaraes — Creixomil

Quebec

  • Ecogene-21 — Chicoutimi
  • Institute de Recherches Cliniques de Montreal — Montreal
  • Nathalie Saint-Pierre — Montreal
  • Clinique des Maladies Lipidiques de Quebec Inc. — Québec

New York

  • CTSI Investigational Pharmacy — New York
  • Milstein Hospital — New York

California

  • Diabetes/Lipid Management & Research Center — Huntington Beach

Florida

  • Excel Medical Clinical Trials, LLC — Boca Raton

Illinois

  • Department of Pharmacy — Park Ridge

Kansas

  • University of Kansas Medical Center (KUMC) — Kansas City

Pennsylvania

  • IDS Central — Philadelphia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-11-18
Est. Completion 2028-02
Phase Phase 3

Sponsor

Ionis Pharmaceuticals

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05130450

The ClinicalTrials.gov registry entry for NCT05130450 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Familial Chylomicronemia Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Olezarsen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05130450 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Quebec, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05130450 about?

NCT05130450 is a clinical study titled "A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)". 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.

What is the current status of trial NCT05130450?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2021-11-18. Estimated completion is 2028-02.

What conditions does trial NCT05130450 study?

This clinical trial studies the following conditions: Familial Chylomicronemia Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05130450?

The interventions under investigation include: Olezarsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05130450?

This trial is sponsored by Ionis Pharmaceuticals, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05130450 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial