RecruitingPhase 3NCT06780410
A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins
Sponsor
Gan & Lee Pharmaceuticals.
Enrollment
240 participants
Start Date
Dec 20, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- \. 18 years and older, male or female.
- \. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.
- \. 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.
- \. 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 Criteria7
- \. 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.
- \. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.
- \. History of malignant tumors prior to screening.
- \. History of drug, alcohol, amphetamines, or other drug abuse.
- \. 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).
- \. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.
- \. Any other factors that the investigator believes makes the participant unsuitable for the study.
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Interventions
DRUGBempedoic Acid Tablet
Once daily, oral
DRUGPlacebo
Once daily, oral
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06780410