Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia
Lead Sponsor:
Akeso
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
Detailed Description
This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholes...
Eligibility Criteria
Inclusion
- 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
- 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.
- Pregnant or lactating women.
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT05255094
Start Date
November 3 2021
End Date
June 22 2022
Last Update
March 6 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, China