Misocholic Tablets for Non-Viral Elevated Liver Enzymes

Prior treatment

• Use of hepatoprotective medications, herbal medicines, or dietary supplements that may influence liver enzymes within 4 weeks before screening.
• Inability to discontinue alcohol consumption or stabilize suspected hepatotoxic medications or products during the study.
• Inability or unwillingness to comply with study procedures, scheduled visits, study medication, or protocol-required assessments.

Other illness

• Evidence or reasonable suspicion of another liver disease that is considered the primary cause of elevated liver enzymes, including:
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus infection (anti-HCV or HCV RNA positive);
  • Suspected acute viral hepatitis (including hepatitis A or E when clinically indicated);
  • Biliary obstruction, gallstones, biliary tract dilation, hepatic or biliary malignancy, or pancreaticobiliary disease identified by imaging;
  • Autoimmune liver disease, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency, or other chronic liver diseases other than NAFLD.
• Extrahepatic causes of elevated aminotransferases, including rhabdomyolysis, acute muscle injury, excessive recent exercise, recent myocardial infarction, severe heart failure, congestive hepatopathy, shock, or severe systemic infection.
• Known hypersensitivity to any component of Misocholic Tab.
• Uncontrolled severe medical illness, active malignancy, or any condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.

Lab values

• Severe liver injury or advanced liver disease, including:
  • ALT or AST ≥5 × ULN;
  • Total bilirubin ≥2 × ULN or clinically significant jaundice;
  • INR ≥1.5 (in participants not receiving anticoagulants);
  • Serum albumin \<30 g/L;
  • Platelet count \<100 × 10⁹/L;
  • Clinical, laboratory, or imaging evidence of advanced cirrhosis or portal hypertension;
  • Ascites, hepatic encephalopathy, gastrointestinal bleeding related to portal hypertension, or decompensated cirrhosis;
  • Requirement for urgent hospitalization or specialist treatment because of liver disease.
• Predominantly cholestatic liver injury, including ALP ≥2 × ULN or liver injury pattern considered unsuitable for evaluation of hepatocellular enzyme reduction.

Other

• Pregnant or breastfeeding women, or women planning pregnancy during the study period.
• Participation in another interventional clinical trial.

• Adults aged 18 years or older.
• Mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) at screening, defined as ALT and/or AST ≥2 to \<5 times the upper limit of normal (ULN) according to the reference range of the study laboratory.
• Elevated liver enzymes primarily associated with one of the following conditions:
  • Alcohol-related liver disease (ALD), defined by: History of hazardous alcohol consumption for at least the previous 3 months (average ethanol intake ≥40 g/day for men or ≥20 g/day for women); Elevated ALT and/or AST consistent with hepatocellular liver injury; At least one supportive feature of alcohol-related liver disease (e.g., elevated GGT, AST/ALT ratio ≥1, hepatomegaly, right upper quadrant discomfort, or hepatic steatosis on ultrasonography); No other liver disease considered the primary cause of liver enzyme elevation.
  • Drug-induced liver injury (DILI), defined by: Exposure to conventional medications, herbal medicines, traditional medicines, or dietary supplements within 180 days before detection of elevated liver enzymes; A reasonable temporal relationship between exposure and liver enzyme elevation; Hepatocellular or mixed liver injury pattern with predominant ALT/AST elevation; RUCAM score classified as possible or higher; No other liver disease considered the primary cause of liver enzyme elevation.
  • Non-alcoholic fatty liver disease (NAFLD), defined by: Evidence of hepatic steatosis on ultrasonography; Elevated ALT and/or AST consistent with hepatocellular liver injury; Alcohol consumption below the diagnostic threshold for alcohol-related liver disease; No other liver disease considered the primary cause of liver enzyme elevation. Willing to comply with study recommendations for management of the underlying cause, including alcohol abstinence or maximal reduction of alcohol intake when appropriate, discontinuation, substitution, or stabilization of suspected hepatotoxic medications or products when clinically feasible, and maintenance of stable background therapy throughout the study.
• Willing to avoid the use of additional hepatoprotective drugs, herbal medicines, or dietary supplements that may significantly affect liver enzyme levels during the study unless medically required.
• Able and willing to provide written informed consent.