To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Percentage changes in LDL-C from baseline to Day 180 and Day 270
Time frame: 80 days and 270 days
Percentage changes in LDL-C from baseline at each subsequent visit to Day 360
Time frame: 360 days
Value changes in LDL-C from baseline at each subsequent visit to Day 360
Time frame: 360 days
Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360
Time frame: 360 days
Value changes in PCSK9 from baseline at each subsequent visit to Day 360
Time frame: 360 days
Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360
Time frame: 360 days
Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360
Time frame: 360 days
Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360
Time frame: 360 days
Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein
Time frame: 360 days
Proportion of participants who attained global lipid modification targets for level of ASCVD risk
Time frame: 360 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments
Time frame: 360 days
ADA incidence
Time frame: 360 days