This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
109
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, China
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12
Time frame: At baseline and week 12
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: From baseline through 12 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: From baseline through 12 weeks
Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol
Time frame: From baseline through 12 weeks
Percent change from baseline in serum Triglyceride (TG) cholesterol
Time frame: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein B (Apo B)
Time frame: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Time frame: From baseline through 12 weeks
Percent change from baseline in Lipoprotein(a) [Lp-(a)]
Time frame: From baseline through 12 weeks
Percent change from baseline in Total Cholesterol(TC)
Time frame: From baseline through 12 weeks
Incidence of treatment-emergent adverse events
Time frame: From baseline through 12 weeks
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Serum concentrations of AK102
Time frame: From baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.
Time frame: From baseline through 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: From baseline through 12 weeks