This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
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 concentration of 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: From baseline to Day 360
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