A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
NCT ID: NCT06780410
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2024-12-20
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bempedoic acid
Once daily
Bempedoic Acid Tablet
Once daily, oral
Placebo
Once daily
Placebo
Once daily, oral
Interventions
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Bempedoic Acid Tablet
Once daily, oral
Placebo
Once daily, oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gan & Lee Pharmaceuticals.
INDUSTRY
Responsible Party
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Locations
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Site 01
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BDP-HLD-301
Identifier Type: -
Identifier Source: org_study_id
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