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RECRUITINGPhase 3INTERVENTIONAL

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

A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form, capable of completing the entire study process. Who Should NOT Join This Trial: - 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 within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer). - 6\. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test. - 7\. Any other factors that the investigator believes makes the participant unsuitable for the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer). * 6\. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test. * 7\. Any other factors that the investigator believes makes the participant unsuitable for the study.

Treatments Being Tested

DRUG

Bempedoic Acid Tablet

Once daily, oral

DRUG

Placebo

Once daily, oral

Locations (1)

Site 01
Beijing, China