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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: Active Phase 3 study of Familial Chylomicronemia Syndrome, sponsored by Ionis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-02-25 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What the registry record for NCT05185843 still lists
NCT05185843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 76-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target (68% lower).
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 lists 11 locations in 8 states (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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