Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07623915

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

This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and older. 2. 18.5 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. 3. Diagnosis with ASCVD or have high-risk ASCVD, and/or diagnosis with HeFH.4.Be on stable lipid-modifying therapy for at least 4 weeks prior to screening, including moderate to high-dose statins with or without other lipid-modifying therapy (cholesterol absorption inhibitors[ezetimibe, Hyzetimibe],fibrates [except gemfibrozil]); 5.Fasting LDL-C must meet any one of the following
  • For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
  • For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL).

6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.

Exclusion criteria

  • Known allergy to any component of the investigational drug or its excipients or related preparations, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
  • Diagnosis with HoFH.
  • History of tendon diseases or tendon ruptures before the screening.
  • Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
  • Hyperthyroidism or uncontrolled hypothyroidism
  • Uncontrolled hypertension
  • Severe cardiovascular or cerebrovascular events in the past 3 months
  • History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
  • Liver disease or dysfunction

Treatment and study plan

Bempedoic Acid Tablet

Drug

bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Placebo

Drug

Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Proportion of participants achieving LDL-C target

    Time frame: Baseline, Week 12

  2. Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12

    Time frame: Baseline, Week 12

  3. 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.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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.

Published trials that share one or more normalized conditions with this study.