Hyperlipidemia Clinical Trial
Official title:
A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
This is a randomized, double-blind, placebo-controlled phase Ⅲ clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | July 31, 2022 |
Est. primary completion date | April 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. 10. Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Akeso |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change from baseline of serum LDL-C level | Percentage change from baseline of serum LDL-C level | At week 12 | |
Secondary | Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels | Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL- | Week 0-12 | |
Secondary | The incidence and severity of adverse events (AE) | The incidence and severity of adverse events (AE) | Week 0-12 | |
Secondary | To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration | To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration | Week 0-12 | |
Secondary | Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity | Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity | Week 0-12 |
Status | Clinical Trial | Phase | |
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