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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Primary Hyperlipidemia

In brief

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.

Key facts

Study ID: NCT07623915
Run by: CSPC Ouyi Pharmaceutical Co., Ltd.
People needed: 222
Starts: 2026-06-12
Expected to finish: 2027-08-28
Last updated by the study team: 2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
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).
Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.

You may not qualify if…

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.
Diagnosis with HoFH.
History of tendon diseases or tendon ruptures before the screening.
Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
Hyperthyroidism or uncontrolled hypothyroidism
Uncontrolled hypertension
Severe cardiovascular or cerebrovascular events in the past 3 months
History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
Liver disease or dysfunction

Full record on ClinicalTrials.gov

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