Status:
RECRUITING
A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
Lead Sponsor:
Gan & Lee Pharmaceuticals.
Conditions:
Primary Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
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.
Key Trial Info
Start Date :
December 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06780410
Start Date
December 20 2024
End Date
October 1 2025
Last Update
January 17 2025
Active Locations (1)
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1
Site 01
Beijing, China