Dihydroartemisinin for MAFLD

Ki vehet részt

• Aged 18-45 years (inclusive), any gender
• Meets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both of the following:
• Evidence of hepatic steatosis (at least one of the following):
• Imaging: Ultrasound, CT, or MRI-PDFF showing liver fat content ≥5%
• Liver biopsy: Histologically confirmed steatosis ≥5% (within 6 months prior to enrollment)
• FibroScan: Controlled Attenuation Parameter (CAP) ≥248 dB/m
• Evidence of metabolic dysfunction (at least one of the following):
• Overweight/Obesity: BMI ≥24 kg/m² or waist circumference ≥90 cm (male) / ≥85 cm (female)
• Elevated blood pressure/Hypertension: Blood pressure ≥130/85 mmHg, or on antihypertensive medication
• Pre-diabetes or Type 2 Diabetes: Fasting blood glucose ≥6.1 mmol/L, or 2-hour post-load glucose ≥7.8 mmol/L, or HbA1c ≥5.7%, or history of T2DM, or HOMA-IR ≥2.5
• Elevated blood triglycerides: Fasting serum TG ≥1.70 mmol/L, or on lipid-lowering medication
• Reduced HDL-cholesterol: Serum HDL ≤1.0 mmol/L (male) / ≤1.3 mmol/L (female), or on lipid-lowering medication
• Participants on glucose-, blood pressure-, or lipid-lowering medications must have been on a stable dose for at least 3 months prior to screening
• All participants must have stable body weight (defined as weight loss or gain not exceeding 5% within 3 months prior to screening and from screening to enrollment)
• Voluntary participation, willingness to cooperate with follow-up, and signed informed consent

Ki nem vehet részt

• Long-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen, amiodarone, oral vitamin E) within the past year
• Use of any category of antibiotics within 2 weeks prior to enrollment
• Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCV-Ab)
• Specific liver diseases that can cause fatty liver (e.g., autoimmune hepatitis, Wilson's disease) or other specific conditions (e.g., total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome)
• History of leukopenia or agranulocytosis
• History of bariatric surgery within the past 2 years
• History of malignancy, cardiovascular disease, chronic kidney disease, decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome), or liver transplantation
• Liver function impairment (defined as any one of ALT, AST, GGT, ALP exceeding 2 times the upper limit of normal (ULN) and/or bilirubin exceeding 1.5 times ULN)
• Excessive alcohol consumption: weekly ethanol intake ≥210 g (male) or ≥140 g (female)
• Pregnant, planning pregnancy, or lactating women
• Considered by the clinical investigator to be unsuitable for participation in the study