This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
This is a Phase 3 clinical study to evaluate the long-term efficacy and safety of AK102, a monoclonal antibody, against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Precentage change from baseline of serum LDL-C level
Time frame: At week 52
The incidence and severity of adverse events (AE)
Time frame: Week 0-52
Value and percentage change from baseline of serum TC levels
Time frame: Week 0-52
Value and percentage change from baseline of serum TG levels
Time frame: Week 0-52
Value and percentage change from baseline of serum non HDL-C levels
Time frame: Week 0-52
Value and percentage change from baseline of serum ApoB levels
Time frame: Week 0-52
Value and percentage change from baseline of serum HDL-C levels
Time frame: Week 0-52
Value and percentage change from baseline of serum ApoA-I levels
Time frame: Week 0-52
Value and percentage change from baseline of serum Lp(a) levels
Time frame: Week 0-52
Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration
Time frame: Week 0-52
Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity
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Time frame: Week 0-52