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Not yet recruiting NCT07623915

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

Phase III Interventional Primary Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bempedoic Acid Tablet, Placebo.
Who it may be relevant to
Registry conditions: Primary Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Bempedoic Acid Tablet
    bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
  • Drug Placebo
    Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Primary outcome measures

  • Percentage change from baseline in LDL-C levels at Week 12 [Time frame: Baseline, Week 12]
Secondary outcome measures (3)
  • Proportion of participants achieving LDL-C target [Time frame: Baseline, Week 12]
  • Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12 [Time frame: Baseline, Week 12]
  • Adverse events (AEs) and serious adverse events (SAEs) during the study [Time frame: Baseline, Week 13]

Eligibility criteria

Inclusion criteria

1\. 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07623915 · SYH9117-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗