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NCT05185843 · ClinicalTrials.gov registry record · Phase 3

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

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

Active
Registry status
Phase 3
Development phase
24
Enrollment target
11
Study locations

NCT05185843 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 24 participants, below the 76-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target (68% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT05185843, 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
24 participants
Enrollment target
11
Study locations

Study Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.

Conditions Studied

Familial Chylomicronemia Syndrome

Interventions

  • DRUG Olezarsen

Study Locations (11)

Quebec

  • Ecogene-21 - Chicoutimi
  • Clinique des Maladies Lipidiques de Quebec Inc. - Québec
  • Centre Hospitalier Universite de Sherbrooke (CHUS) - Sherbrooke

British Columbia

  • Centre for Heart Lung Innovation - Vancouver
  • ARC Biosystems, Clinical Assessment Unit (CAU) - Vancouver

California

  • Diabetes/Lipid Management & Research Center - Huntington Beach

Florida

  • Excel Medical Clinical Trials, LLC - Boca Raton

Michigan

  • University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND) - Ann Arbor

New York

  • University of Rochester School of Medicine - Rochester

Manitoba

  • St. Boniface General Hospital - Winnipeg

Other

  • Karolinska University Hospital Huddinge - Stockholm

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-02-25
Est. Completion 2027-06
Phase Phase 3

Sponsor

Ionis Pharmaceuticals

76 total trials

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What the Registry Record Tells You About NCT05185843

The ClinicalTrials.gov registry entry for NCT05185843 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 76-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target (68% 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.

NCT05185843 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Quebec, British Columbia, California.

Frequently Asked Questions

What is clinical trial NCT05185843 about?

NCT05185843 is a clinical study titled "A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen". The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.

What is the current status of trial NCT05185843?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2022-02-25. Estimated completion is 2027-06.

What conditions does trial NCT05185843 study?

This clinical trial studies the following conditions: Familial Chylomicronemia Syndrome.

What interventions are being tested in trial NCT05185843?

The interventions under investigation include: Olezarsen (DRUG).

Who is sponsoring clinical trial NCT05185843?

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

Where is trial NCT05185843 being conducted?

This trial has 11 study locations across California, Florida, Michigan, New York, British Columbia. 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.