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

Akeso464 enrolled

Overview

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.

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 hypercholesterolemia and mixed hyperlipidemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

464

Conditions

Hyperlipidemia

Interventions

AK102BIOLOGICAL

Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

AK102BIOLOGICAL

Administered AK102 by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

PlaceboDRUG

Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, China

Outcomes

Primary Outcomes

Percentage change from baseline of serum LDL-C level

Time frame: At week 12

Secondary Outcomes

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-

Time frame: Week 0-12

The incidence and severity of adverse events (AE)

Time frame: Week 0-12

To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

Time frame: Week 0-12

Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

Time frame: Week 0-12

Data from ClinicalTrials.gov

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