A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With 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.

Inclusion criteria

• Subject understand and voluntarily sign the written Inform Consent Form (ICF), which must be signed before performing the study procedures.
• Male or female patients aged between 18 and 80 years (including upper and lower limits).
• 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.
• Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion criteria

• Homozygous Familial Hypercholesterolemia (HoFH).
• Received PCSK9 inhibitors within 6 months before randomization.
• Known sensitivity to PCSK9 inhibitors and any substances to be administered.
• Severe liver and 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.
• Pregnant or lactating women.