Evaluating Bempedoic Acid for treating high cholesterol

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

This study is testing if Bempedoic Acid can help people with high cholesterol who haven't had enough success with statins to lower their cholesterol levels better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gan & Lee Pharmaceuticals. (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT06780410 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to assess the efficacy, tolerability, and safety of Bempedoic Acid tablets in patients suffering from primary hyperlipidemia who have not achieved adequate control with statin therapy. Participants will be randomly assigned to receive either Bempedoic Acid or a placebo, with the goal of determining how well the medication works in lowering cholesterol levels. The study will involve monitoring participants for side effects and overall health outcomes throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with primary hyperlipidemia who have not achieved adequate cholesterol control with statins.

Not a fit: Patients with severe hyperlipidemia (fasting triglycerides ≥ 5.64 mmol/L) or those with a history of allergic reactions to the study drug will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective alternative for patients struggling to manage their cholesterol levels with existing medications.

How similar studies have performed: Other studies have shown promise in using Bempedoic Acid for cholesterol management, indicating potential for success in this approach.

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.

Where this trial is running

Beijing

• Site 01 — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Wei Zhao

Conditions: Primary Hyperlipidemia, Bempedoic Acid, Hyperlipidemia, Efficacy, Safety