None listed
Conditions
Interventions
Drug : Participants will be randomly assigned in a 1:1 ratio to either the silymarin monotherapy group or the combination therapy group of silymarin plus biphenyl dimethyl dicarboxylate/ursodeoxycholi
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older and younger than 75 years. 2) Participants with fatty liver confirmed by imaging tests, such as abdominal ultrasonography, and CAP(Controlled Attenuation Parameter) = 280 dB/m. 3) Participants who meet at least one of the following diagnostic criteria for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease): ? Overweight or obesity (BMI = 23 kg/m²) ? Diagnosed with type 2 diabetes mellitus ? Hypertriglyceridemia with triglycerides (TG) = 150 mg/dL ? Low HDL cholesterol: <40 mg/dL in men or <50 mg/dL in women ? Blood pressure = 130/85 mmHg 4) Participants with underlying diseases such as type 2 diabetes mellitus, hypertension, or dyslipidemia who have been clinically stable on medication for the relevant condition without changes in drug type or dose for at least 12 weeks (3 months) before study participation. 5) Participants with an average alcohol intake over the past 3 months of 210–420 g/week for men or 140–350 g/week for women. 6) Participants whose ALT or AST level is within 1 to 5 times the upper limit of normal (ULN). 7) Participants with total bilirubin = 2.0 mg/dL and INR = 1.3. 8) Participants with platelet count = 100,000/µL. 9) Participants with eGFR = 45 mL/min/1.73 m².
Exclusion criteria
Exclusion criteria: 1) Participants with alcohol intake exceeding the MetALD range or with acute alcoholic hepatitis. 2) Participants with positive HBsAg, positive anti-HIV antibody, positive HCV RNA at screening, or known presence of HCV RNA or HBsAg within 2 years prior to screening. 3) Participants with chronic liver disease due to other causes, such as viral hepatitis, primary biliary cholangitis/primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), Wilson’s disease, hemochromatosis, or alpha-1 antitrypsin deficiency. 4) Participants with decompensated cirrhosis corresponding to a Child-Pugh score of 10 or higher (Child-Pugh class C) or a MELD (Model for End-Stage Liver Disease) score of 20 or higher. Decompensated cirrhosis (Child-Pugh class B/C) refers to a condition in which liver function is severely impaired and complications such as ascites, jaundice, hepatic encephalopathy, or variceal bleeding may occur. According to the Korean Association for the Study of the Liver guidelines for liver cirrhosis, Child-Pugh class is categorized according to liver function as follows: Class A: total score 5–6, well-preserved liver function; Class B: total score 7–9, moderately impaired liver function; Class C: total score 10–15, impaired liver function. 5) Participants with clinically significant drug-induced liver injury (DILI) within the past 3 months. 6) Participants with active malignancy, pregnant women, or lactating women. 7) Participants with severe alcohol use disorder or psychiatric illness that makes compliance with the study impossible. 8) Participants who have taken hepatoprotective agents or other drugs for liver disease, such as BDD (biphenyl dimethyl dicarboxylate), UDCA (ursodeoxycholic acid), or silymarin, within at least 12 weeks (3 months) before study participation and have not completed a washout period of at least 3 months after taking the relevant drug. 9) Participants with complete or severe biliary obstruction. 10) Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 11) Participants with uncontrolled diabetes mellitus, defined as HbA1c = 9.0%. 12) Participants with hypersensitivity to the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in AST(aspartate aminotransferase) or ALT(alanine aminotransferase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in GGT(Gamma-Glutamyl Transferase);Change in HbA1c(Hemoglobin A1c);Change in insulin resistance index (HOMA-IR) = 2.0;Change in Triglyceride(TG);Change in CAP(Controlled Attenuation Parameter) or LSM(Liver Stiffness Measurement) measured by FibroScan;Change in QoL(Quality of Life) score;Change in PEth(Phosphatidylethanol);Change in AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Kul Jung
Korea University Ansan Hospital
Outcome results
None listed