Evaluating Bempedoic Acid for treating high cholesterol
Official title: A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins
Run by Gan & Lee Pharmaceuticals. · NCT06780410 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Gan & Lee Pharmaceuticals. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | October 2025 |
| Study ends | October 2025 |
| Registry record updated | January 17, 2025 |
| Trial ID | NCT06780410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using Bempedoic Acid for cholesterol management, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Site 01
Beijing, China Recruiting
Study contacts
- Study coordinator: Wei Zhao
- Email: wei.zhao@ganlee.com
- Phone: 010-56456726
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.