A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With 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.

Inclusion criteria

• Subject understand and voluntarily sign the written Inform Consent Form (ICF).
• Male or female ≥ 18 to ≤ 80 years of age.
• The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
• TG ≤ 4.5 mmol/L (400 mg/dl)

Exclusion criteria

• Known homozygous familial hypercholesterolemia.
• Received PCSK9 inhibitors within 6 months before randomization.
• Known sensitivity to PCSK9 inhibitors and any substances to be administered.
• Severe renal dysfunction.
• Previously received organ transplantation.
• Uncontrolled hypothyroidism or hyperthyroidism.
• Uncontrolled hypertension.
• Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
• History of malignancy of any organ system within the past 5 years.