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Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
NCT06822790 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.
Conditions Studied
Interventions
- DRUG Plozasiran Injection
Study Locations (20)
Florida
- Research Site 155 — Fort Lauderdale
- Research Site 14 — Hialeah
- Research Site 154 — Miami
- Research Site 1 — Miami Lakes
- Research Site 162 — Mt. Dora
- Research Site 42 — Mt. Dora
- Research Site 38 — North Miami
- Research Site 159 — Orlando
- Research Site 41 — Orlando
- Research Site 16 — Tamarac
- Research Site 18 — Tampa
California
- Research Site 21 — Bakersfield
- Research Site 9 — Beverly Hills
- Research Site 11 — Canoga Park
- Research Site 40 — Garden Grove
- Research Site 39 — Lincoln
- Research Site 34 — Oxnard
Indiana
- Research Site 167 — Elkhart
- Research Site 43 — Elkhart
Illinois
- Research Site 17 — Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 869 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06822790
The ClinicalTrials.gov registry entry for NCT06822790 describes a study currently listed as 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 869 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 Hypertriglyceridemia appearing as the primary indexed condition, and to 1 intervention — of which Plozasiran Injection 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: NCT06822790 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Indiana. 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 NCT06822790 about?
NCT06822790 is a clinical study titled "Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia". This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canad...
What is the current status of trial NCT06822790?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 869 participants. The study started on 2025-04-09. Estimated completion is 2028-07.
What conditions does trial NCT06822790 study?
This clinical trial studies the following conditions: Hypertriglyceridemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06822790?
The interventions under investigation include: Plozasiran Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06822790?
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 NCT06822790 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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