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NCT Number: NCT06780410

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bempedoic Acid Tablet

Drug

Once daily, oral

Placebo

Drug

Once daily, oral

Primary outcomes

  1. Percentage change from baseline in LDL-C levels at Week 12

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percentage change from baseline in total cholesterol (TC) levels at Week 12

    Time frame: Baseline, Week 12

  2. Adverse events (AEs) and serious adverse events (SAEs) during the study

    Time frame: Baseline, Week 13

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhao

CONTACT

[email protected]

010-56456726

Sponsors and collaborators

Lead sponsor

Gan & Lee Pharmaceuticals.

Industry

Registry information

Official study title

A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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