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

Launched by GAN & LEE PHARMACEUTICALS. · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Bempedoic Acid, which is being tested for its effectiveness in lowering cholesterol levels in adults who have high cholesterol (also known as hyperlipidemia) that is not well controlled by standard treatments like statins. The trial is currently looking for participants aged 18 and older, regardless of gender, who have a body mass index (BMI) between 18 and 35. To participate, individuals must be able to understand the study and provide written consent, and they need to agree to use reliable birth control during the trial.

Participants in this trial can expect to take Bempedoic Acid tablets and attend regular check-ups to monitor their health. It's important to note that those with certain conditions, such as severe allergies to the medication, very high triglyceride levels, a history of cancer, or substance abuse, will not be eligible to join. Overall, this study aims to determine how well Bempedoic Acid works, how safe it is, and how well people tolerate it.

Gender

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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 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.