To evaluate the efficacy, safety and immunogenicity of QCL7401 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
780
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: From baseline to Day 330
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C
Time frame: Day 90 to Day 360
Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Time frame: From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs
Time frame: Throughout the study duration]
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