The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
Percent Change from Baseline in LDL-C at Week 12
Time frame: Week 12
Change From Baseline in LDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at Week 12
Time frame: Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
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Percent Change From Baseline in Triglycerides at Week 12
Time frame: Week 12
Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in ApoB at Week 12
Time frame: Week 12
Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Apo A1 at Week 12
Time frame: Week 12
Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Lipo(a) at Week 12
Time frame: Week 12
Number of investigational product-related adverse events
Time frame: Weeks 12 and 20
Number of ADA and Nab
Time frame: Week 20