NCT06796426

Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS

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).

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Familial Chylomicronemia
• High Risk Severe Hypertriglyceridemia (SHTG)

Interventions

Type	Name	Description
DRUG	Plozasiran	25 mg ARO-APOC3 by sc injection administered by healthcare professional

Timeline

• First posted: 2025-01-28
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States