Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and … (NCT06796426) | Clinical Trial Compass
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Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
United States
Plain-language 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.
Who can participate
Age range15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
FCS Inclusion Criteria:
* ≥ 15 years of age
* Fasting TG levels ≥ 880 mg/dL that are not sufficiently controlled on standard lipid-lowering therapy
* Established diagnosis of FCS based on documented history of fasting TG levels in excess of 1000 mg/dL on repeated testing (for at least 3 prior occasions), and at least 1 of the following: a supportive genetic test, documented history of recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis, documented history of recurrent hospitalizations for severe abdominal pain without other explainable cause, documented history of childhood pancreatitis, family history of hypertriglyceridemia-induced pancreatitis
* Willing to follow dietary counseling based on local standard of care, consistent with an intake of ≤ 20 g of fat per day
* If on medications for management of type 2 diabetes the dosing regimen must be stable.
* Participants of childbearing potential must agree to use a highly effective form of contraception in addition to a male condom during the program and for at least 90 days after the last dose of plozasiran
SHTG Inclusion Criteria:
* Established diagnosis of high risk SHTG and documented evidence (medical history) of either: fasting triglycerides (TG) ≥ 880 mg/dL OR fasting TG levels of ≥ 500 mg/dL AND history of recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis
* Hemoglobin A1c (HbA1c) ≤ 9.0% at Day 1
* Fasting low density lipoprotein cholesterol (LDL-C) ≤130 mg/…