A Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.

Inclusion Criteria:

1. 18 years and older. 2. 18.5 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. 3. Diagnosis with ASCVD or have high-risk ASCVD, and/or diagnosis with HeFH.4.Be on stable lipid-modifying therapy for at least 4 weeks prior to screening, including moderate to high-dose statins with or without other lipid-modifying therapy (cholesterol absorption inhibitors[ezetimibe, Hyzetimibe]，fibrates [except gemfibrozil]）; 5.Fasting LDL-C must meet any one of the following

1. For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
2. For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL).

6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.

Exclusion Criteria:

1. Known allergy to any component of the investigational drug or its excipients or related preparations, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
2. Diagnosis with HoFH.
3. History of tendon diseases or tendon ruptures before the screening.
4. Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
5. Hyperthyroidism or uncontrolled hypothyroidism
6. Uncontrolled hypertension
7. Severe cardiovascular or cerebrovascular events in the past 3 months
8. History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
9. Liver disease or dysfunction