Misocholic tablets trial for raised liver enzymes from non-viral causes

Trial details

Who runs it

Hanoi Medical University

Trial code

NCT07833514

Record updated

22 September 2026

Original description

Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited.Read full original descriptionShow less

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Misocholic Film-Coated Tablets in Patients With Non-Viral Elevated Liver Enzymes

Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited.

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin.

The primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.

Inclusion: 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.

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

ClinicalTrials.gov NCT07833514