This is a randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.
This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, 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
246
Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhongshan Hospital, Fudan Hospital
Shanghai, China
Percentage change from baseline of serum LDL-C level
Time frame: At week 12
Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels
Time frame: Week 0-24
The incidence and severity of adverse events (AE)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(t1/2)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(AUC)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Vd)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Tmax)
Time frame: Week 0-24
Evaluate the changes of free PCSK9 concentration
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Cmax)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(CL)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(MRT)
Time frame: Week 0-24
The number and percentage of anti AK102 antibody (ADA)positive subjects
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Time frame: Week 0-24
The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects
Time frame: Week 0-24
the time of ADA positive
Time frame: Week 0-24
the time of nab positive
Time frame: Week 0-24