Status:
COMPLETED
A Study to Evaluate the Long-term 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 long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidem...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05255458
Start Date
November 4 2021
End Date
January 9 2023
Last Update
February 28 2025
Active Locations (1)
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1
The Third Hospital of Nanchang
Nanchang, Jiangxi, China, 330009