Zhibitai Capsules for the Treatment of Primary Hyperlipidemia

Inclusion criteria

• Age between 18 and 75 years old (inclusive), regardless of gender;
• BMI (Body Mass Index) between 18.0 kg/m² and 30.0 kg/m²;
• Meets the diagnostic criteria for primary hyperlipidemia (tan yu hu jie, qi xue bu li zheng);
• LDL-C level ≥ 3.4 mmol/L and TG level ≤ 4.5 mmol/L;
• Diagnosis before and after the run-in period meets the above criteria, and the absolute difference between the two LDL-C measurements before and after the run-in period does not exceed 12%;
• Agrees to follow dietary and lifestyle modification guidance during the trial, maintain a stable diet and exercise routine throughout the study, take medication as required, and complete diary cards;
• Agrees to participate in this clinical trial and voluntarily signs the informed consent form.

Exclusion criteria

• Known or suspected allergy to any component of the investigational product, or having an allergic constitution.
• According to the "Chinese Guidelines for Lipid Management (2023)", individuals classified as being at very high risk or extremely high risk for ASCVD.
• Confirmed homozygous familial hypercholesterolemia.
• Dyslipidemia caused by secondary reasons, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen storage disease, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, drug-induced causes (e.g., phenothiazines, beta-blockers, glucocorticoids, certain contraceptives, etc.), or patients currently using heparin, thyroid hormone therapy, or other medications that affect lipid metabolism.
• Any surgical or medical condition that may significantly affect the absorption, distribution, metabolism, or excretion of the drug:

• History of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection; ② Active or recurrent irritable bowel syndrome (IBS) or inflammatory bowel disease (except for those asymptomatic for at least 6 months prior to the screening visit);

• Current active gastritis, active ulcer, or gastrointestinal bleeding;

• History of pancreatic or gallbladder disease (except for those with prior cholecystectomy).
• Previous use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, such as evolocumab and alirocumab.
• Use of lipid-lowering drugs within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer), such as statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, niacin, high-purity fish oil preparations, weight-loss drugs (e.g., GLP-1 receptor agonists), and other traditional Chinese medicines, health products, or hospital preparations (e.g., formula granules, herbal decoctions) with clear lipid-lowering effects as stated in the instructions.
• History of acute or chronic liver disease, drug-induced liver injury, or cirrhosis (except for mild fatty liver indicated by abdominal ultrasound).
• ALT or AST ≥ 2 times the upper limit of normal (ULN), SCr > ULN, total bilirubin (TBIL) ≥ 1.5 times ULN, creatine kinase ≥ 3 times ULN, or any other laboratory test result (blood routine, urine routine, blood biochemistry) exceeding the ULN, and judged by the investigator as potentially affecting efficacy or safety evaluation.
• History of any of the following severe cardiovascular or cerebrovascular diseases:

① Unstable angina or coronary artery bypass grafting within 3 months prior to the screening visit, or percutaneous coronary intervention.

• Myocardial infarction, shock, life-threatening arrhythmia, or significant ECG abnormalities (e.g., ST-segment abnormalities, pathological Q waves, abnormal QTc interval, etc.) within 6 months prior to the screening visit.

• History of left ventricular outflow tract obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).

• Heart failure ≥ Class II (NYHA classification) at screening. ⑤ Acute stroke within 6 months prior to the screening visit, excluding asymptomatic stroke.
• Uncontrolled hypertension (history of hypertension with regular medication, and two consecutive blood pressure measurements ≥ 180/110 mmHg at screening), or history of type 1 diabetes, diabetic ketoacidosis, or uncontrolled type 2 diabetes (HbA1c > 7%).
• Patients with other severe metabolic diseases.
• History of myositis, myopathy, or rhabdomyolysis, severe muscle abnormalities, and neuropathy.
• Thyroid dysfunction (e.g., hyperthyroidism, hypothyroidism, etc.) (except for those judged by the investigator as clinically insignificant).
• Proven intolerance or inefficacy to HMG-CoA reductase inhibitors.
• History of malignancy within 5 years prior to the first dose, excluding cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin that has been clinically cured for 5 years.
• Pregnant or lactating women, or individuals of either gender with plans for pregnancy within the next 3 months.
• Suspected or confirmed history of alcohol, drug, or substance abuse.
• Individuals with special dietary requirements who cannot adhere to the required diet and exercise control, including but not limited to those following extreme weight-loss diets, undergoing or planning to undergo intense exercise programs (e.g., marathon training, fitness training), or intending to start such training during the trial.
• Positive for any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis-specific antibody (TPHA).
• Participation in other interventional clinical trials within the past 3 months.
• Individuals deemed unsuitable for participation in this clinical trial by the investigator.