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

  • End date
    Jan 31, 2023
  • participants needed
  • sponsor
Updated on 14 March 2022
hmg-coa reductase inhibitors
serum low density lipoprotein


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.

Condition Hyperlipidemia
Treatment Placebo, AK102
Clinical Study IdentifierNCT05255458
Last Modified on14 March 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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