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NCT05130450 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Familial Chylomicronemia Syndrome, sponsored by Ionis Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
60
Enrollment target
20
Study locations

NCT05130450 is a Phase 3 study of Familial Chylomicronemia Syndrome that is active but no longer recruiting, run by Ionis Pharmaceuticals. The registered enrollment target is 60 participants, below the 67-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05130450, a Phase 3 study of Familial Chylomicronemia Syndrome, is active but no longer recruiting, sponsored by Ionis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
60 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Familial Chylomicronemia Syndrome

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

76 total trials

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What the Registry Record Tells You About NCT05130450

The ClinicalTrials.gov registry entry for NCT05130450 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target (10% lower). The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.

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.

NCT05130450 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Quebec, New York.

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.

What interventions are being tested in trial NCT05130450?

The interventions under investigation include: Olezarsen (DRUG).

Who is sponsoring clinical trial NCT05130450?

This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.