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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Site 01

Beijing, China

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid | DecenTrialz