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ACTIVE NOT RECRUITING Phase 3

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

NCT05089084 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 75 participants
Start Date 2021-12-14
Est. Completion 2026-04
Phase Phase 3

Sponsor

Arrowhead Pharmaceuticals

11 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05089084 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, New York, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05089084?

The interventions under investigation include: Placebo (DRUG), Plozasiran (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05089084?

This trial is sponsored by Arrowhead Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial