Dyslipidemia
Conditions
Interventions
Test group:Zhibitai + Ezetimibe
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Dyslipidemia patients with mildly elevated liver enzymes: ALT and/or AST >1×ULN but <3×ULN, with intermediate-to-high ASCVD risk (assessed according to Chinese Guidelines for Lipid Management 2023); 3. Willing to receive and comply with dietary education during the study; 4. For patients with previous lipid-lowering medication use: 2-week washout period before grouping and treatment; 5. Baseline LDL-C level: 3.4-4.9 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Severe hypertriglyceridemia (fasting TG >5.6 mmol/L); 2. Critically ill patients (e.g., severe arrhythmia, severe organic diseases/electrolyte disorders, severe valvular heart disease, malignant tumors); 3. CKD stages 4-5; 4. Active infectious diseases (HBV/HCV/HIV) or decompensated liver dysfunction; 5. Secondary dyslipidemia; 6. Use of hepatoprotective drugs within 3 months; 7. Pregnant or lactating women; 8. Patients with drug allergies; 9. Current participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in fasting LDL-C levels after 12 weeks between groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in fasting Non-HDL-C levels after 12 weeks;The achievement rates of fasting LDL-C and Non-HDL-C in both groups after 12 weeks.;Changes in fasting TG from baseline and between-group differences after 12 weeks;Changes in fasting other lipid parameters (including TC, HDL-C, Lp(a), remnant cholesterol, ApoA1, ApoB) from baseline and between-group differences after 12 weeks;Difference in BMI change from baseline after 12 weeks between the two groups; | — |
Countries
China
Contacts
Public ContactZhu Ye
West China Hospital, Sichuan University
Outcome results
None listed