Hyperlipidemia
Conditions
Interventions
Placebo group:Placebo
Beipaidu Acid Tablets Group:Beipaidu Acid Tablets
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. 18.5 kg/m^2 = 2.6 mmol/L (or 100 mg/dL) at V1 and V3; (2) ASCVD very high-risk participants: LDL-C >= 1.8 mmol/L (or 70 mg/dL) at V1 and V3; ASCVD ultra-high-risk participants: LDL-C >= 1.4 mmol/L (or 55 mg/dL) at V1 and V3. 6. Good compliance during the single-blind statin background lipid-lowering therapy, placebo of bempedoic acid tablets, +/- ezetimibe (if any), with compliance >= 80% and <=120%. 7. Male or female participants who have no reproductive plans (including sperm or egg donation) from the time of signing the ICF until one month after the end of administration and agree to use effective contraception. 8. Fully understand the purpose and requirements of this study, voluntarily participate in the clinical study, and sign the written ICF.
Exclusion criteria
Exclusion criteria: 1. Individuals with a known history of allergy to any component of the investigational drug or its excipients, with allergic diseases (asthma, urticaria, eczema, etc.), or with an allergic constitution. 2. Participants diagnosed with HoFH (see Appendix 13.9.2). 3. Individuals with a history of tendon disease or tendon rupture prior to screening. 4. Individuals with a confirmed or suspected diagnosis of type 1 diabetes, or other specific types of diabetes caused by other reasons (monogenic diabetes syndromes, cystic fibrosis, pancreatitis, drug-induced or chemically-induced diabetes, etc.) prior to screening. 5. Individuals with severe, uncontrolled comorbidities that may affect the absorption and metabolism of the investigational drug or have a significant impact on lipid levels at the time of screening, including but not limited to severe active infections, gastrointestinal diseases or postoperative status (including bariatric surgery), immune system diseases (such as systemic lupus erythematosus), etc. 6. Individuals with hyperthyroidism or uncontrolled stable hypothyroidism at screening (controlled stable refers to receiving a stable dose of thyroid hormone replacement therapy for at least 3 months with TSH within the normal range at screening), or individuals with clinically significant abnormal thyroid function test results at screening. 7. Individuals with uncontrolled hypertension at screening, defined as resting systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg. 8. Individuals who experienced an acute gout attack within 3 months prior to screening. 9. Serious cardiovascular and cerebrovascular events occurring within 3 months before screening or from introduction to randomization, including: unexplained syncope, uncontrolled symptomatic arrhythmias (e.g., atrial fibrillation, starting or changing dosage of arrhythmia medications within 3 months prior to screening), decompensated heart failure (NYHA grade III or IV), unstable angina, acute myocardial infarction, cerebrovascular accidents (e.g., cerebral infarction, cerebral hemorrhage), transient ischemic attacks, coronary artery bypass grafting, Percutaneous coronary intervention, peripheral vascular intervention, or planning to undergo major surgery or interventional procedures during the study period (such as percutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral vascular reconstruction). 10. Any type of treated or untreated malignant tumor within 5 years prior to screening or prior to randomization (excluding clinically cured basal cell carcinoma or carcinoma in situ). 11. Prior to screening, any of the following medications/treatment history: (1) Within 4 weeks prior to screening, the following medications: Xuelicon, niacin and its derivatives, steranols, bile acid chelating agents, containing red yeast rice or other ingredients deemed by the investigator to affect blood lipids; (2) Use of potent CYP enzyme inhibitors, inducers (see Appendix 13.5), or probenecid within 30 days prior to medication; (3) Use of ACL inhibitors within 3 months prior to screening or previous use of this product with poor efficacy or adverse reactions; (4) Lipoprotein plasma exchange within 3 months prior to screening; (5) Use of PCSK9 monoclonal antibodies or small molecule inhibitors within 6 months prior to screening; (6) Use of small RNA-interfering lipid-lowering drugs, such as Incslan sodium injection, within 2 ye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in LDL-C levels from baseline at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma drug concentrations of bempedoic acid and its active metabolite;Proportion of participants reaching LDL-C target at 12 weeks of treatment;Number and incidence of AEs and SAEs occurring during the study;Percentage change in non-HDL-C, ApoB, TC, and hs-CRP levels from baseline at 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactYuan Zuyi
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed