Hyperlipidemia Clinical Trial
Official title:
A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
This is a randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Subject understand and voluntarily sign the written Inform Consent Form (ICF). 2. Male or female = 18 to = 80 years of age. 3. 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. 4. TG = 4.5 mmol/L (400 mg/dl) Exclusion Criteria: 1. Known homozygous familial hypercholesterolemia. 2. Received PCSK9 inhibitors within 6 months before randomization. 3. Known sensitivity to PCSK9 inhibitors and any substances to be administered. 4. Severe renal dysfunction. 5. Previously received organ transplantation. 6. Uncontrolled hypothyroidism or hyperthyroidism. 7. Uncontrolled hypertension. 8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc. 9. History of malignancy of any organ system within the past 5 years. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Zhongshan Hospital, Fudan Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Akeso |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change from baseline of serum LDL-C level | At week 12 | ||
Secondary | Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels | Week 0-24 | ||
Secondary | The incidence and severity of adverse events (AE) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(t1/2) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(AUC) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(Vd) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(Tmax) | Week 0-24 | ||
Secondary | Evaluate the changes of free PCSK9 concentration | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(Cmax) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(CL) | Week 0-24 | ||
Secondary | Evaluate the changes of AK102 PK parameters(MRT) | Week 0-24 | ||
Secondary | The number and percentage of anti AK102 antibody (ADA)positive subjects | Week 0-24 | ||
Secondary | The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects | Week 0-24 | ||
Secondary | the time of ADA positive | Week 0-24 | ||
Secondary | the time of nab positive | Week 0-24 |
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