A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Primary Hyperlipidemia
In brief
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.
Key facts
- Study ID
- NCT06780410
- Run by
- Gan & Lee Pharmaceuticals.
- People needed
- 240
- Starts
- 2024-12-20
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-01-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Site 01 — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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