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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: Active Phase 3 study of Familial Chylomicronemia, sponsored by Arrowhead Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05089084 still lists
NCT05089084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05089084's enrollment target sits among peer trials
75 1774th of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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