Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
Public ClinicalTrials.gov record NCT06796426. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Treatment Protocol for the Use of Plozasiran in Adults With Familial Chylomicronemia Syndrome (FCS). A Single Patient Protocol for the Use of Plozasiran In Adolescents With Familial Chylomicronemia Syndrome (FCS). An Expanded Access Treatment Protocol for Use of Plozasiran In Adults With High-Risk Severe Hypertriglyceridemia (SHTG).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a treatment program for the use of plozasiran in adults (AROAPOC3-EAP-002) and adolescents (AROAPOC3-EAP-003) with familial chylomicronemia syndrome (FCS) as well as in adults (AROAPOC3-EAP-004) with high risk severe hypertriglyceridemia (SHTG). The program will enroll eligible patients ≥ 15 years of age, with fasting triglycerides (TGs) ≥ 880 mg/dL (≥ 10 mmol/L) that is not adequately controlled with standard lipid-lowering therapy, and with a diagnosis of FCS. Patients will receive 25 mg of plozasiran by subcutaneous (sc) injection on Day 1 and every 3 months for a total of 5 injections. The duration of the program is 15 months. The program will also enroll eligible patients ≥18 years of age, with fasting TGs \> 880 mg/dL (\> 9.94 mmol/L), or fasting TGs \> 500 mg/dL plus a history of acute pancreatitis, that are not adequately controlled with standard lipid-lowering therapy, and with a diagnosis of high risk SHTG. SHTG patients will receive 25 mg of plozasiran by sc injection on Day 1 and every 3 months for a total of 7 injections. The duration of the program is 21 months.
Study identification
- NCT ID
- NCT06796426
- Recruitment status
- Available
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 15 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Mar 2, 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arrowhead Pharmaceuticals, Inc. | Pasadena | California | 91105 | Available |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06796426, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 2, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06796426 live on ClinicalTrials.gov.