High Risk Severe Hypertriglyceridemia (SHTG)

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Review clinical trials related to High Risk Severe Hypertriglyceridemia (SHTG). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Available

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

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.

Trial details
Age: 15+Biological sex: AllType: Expanded AccessSponsor: Arrowhead PharmaceuticalsUpdated: Mar 3, 2026Locations: 1
Eligibility criteria

≥ 15 years of age [+11]

Diabetes mellitus with any of the following at Day 1: newly diagnosed within the... [+13]