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NCT05089084 · ClinicalTrials.gov registry record · Phase 3
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
A Phase 3 study of Familial Chylomicronemia, sponsored by Arrowhead Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT05089084 is a Phase 3 study of Familial Chylomicronemia that is active but no longer recruiting, run by Arrowhead Pharmaceuticals. The registered enrollment target is 75 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT05089084, a Phase 3 study of Familial Chylomicronemia, is active but no longer recruiting, sponsored by Arrowhead Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Plozasiran
Study Locations (20)
Other
- Clinical Site 10 - Córdoba
- Clinical Site 11 - Formosa
- Clinical Site 12 - Melbourne
- Clinical Site 13 - Nedlands
- Clinical Site 17 - Graz
- Clinical Site 18 - Edegem
- Clinical Site 19 - Ghent
- Clinical Site 20 - Leuven
New York
- Clinical Site 7 - New York
- Clinical Site 6 - New York
New South Wales
- Clinical Site 14 - Camperdown
- Clinical Site 15 - St Leonards
Florida
- Clinical Site 1 - Boca Raton
Georgia
- Clinical Site 2 - Suwanee
Indiana
- Clinical Site 3 - Indianapolis
Maryland
- Clinical Site 4 - Elkridge
Missouri
- Clinical Site 5 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05089084
The ClinicalTrials.gov registry entry for NCT05089084 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arrowhead Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Familial Chylomicronemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05089084 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, New York, New South Wales.
Frequently Asked Questions
What is clinical trial NCT05089084 about?
NCT05089084 is a clinical study titled "Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)". The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered su...
What is the current status of trial NCT05089084?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2021-12-14. Estimated completion is 2026-04.
What conditions does trial NCT05089084 study?
This clinical trial studies the following conditions: Familial Chylomicronemia.
What interventions are being tested in trial NCT05089084?
The interventions under investigation include: Placebo (DRUG), Plozasiran (DRUG).
Who is sponsoring clinical trial NCT05089084?
This trial is sponsored by Arrowhead Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05089084 being conducted?
This trial has 20 study locations across Florida, Georgia, Indiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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