This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia.
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, when used in combination with stable, background atorvastatin therapy in adult patients with hypercholesterolemia and mixed dyslipidemia. The study is structured into four distinct periods to ensure patient eligibility, standardize background therapy, and assess both short-term and longer-term effects of the investigational product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of SAL003 was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of Placebo was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,510120
Guangzhou, Guangdong, China
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24.
Time frame: at Week 24
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Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of Placebo was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.