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

NCT06796426 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-03-03

No results posted yet for this study

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

DRUG

Plozasiran

25 mg ARO-APOC3 by sc injection administered by healthcare professional

Sponsors & Collaborators

  • Arrowhead Pharmaceuticals

    lead INDUSTRY

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796426 on ClinicalTrials.gov