A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
Eligibility Criteria
Inclusion Criteria: * 1\. 18 years and older, male or female. * 2\. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. * 3\. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes. * 4\. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process. Exclusion Criteria: * 1\. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution. * 2\. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening. * 3\. History of malignant tumors prior to screening. * 4\. History of drug, alcohol, amphetamines, or other drug abuse. * 5\. Participation in other clinical studies and use of other investigational drugs or medical devices