This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Eligible patients will be randomly assigned to receive either Fuzheng Huayu Tablets or placebo for 72 weeks. The primary objective is to assess the improvement in liver fibrosis, measured by liver stiffness reduction via FibroScan. Secondary objectives include changes in liver function indicators, liver fibrosis markers, Child-Pugh score, and safety profile.
Aged 18 to 75 years (inclusive of both upper and lower limits).
History or current hepatic decompensation events at screening, including but not limited to the following: a) Esophagogastric variceal bleeding; b) Hepatic ascites requiring diuretic treatment; c) Hepatic encephalopathy (West Haven grade 2 or above); d) Hepatorenal syndrome.
Having a history or evidence of other chronic liver diseases, such as alcoholic liver disease, drug-induced liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis, history of biliary obstruction or biliary shunt, metastatic liver cancer; Hepatitis B (HBsAg positive); Hepatitis C (HCV antibody positive and HCV-RNA positive). Subjects with previous hepatitis C treatment must maintain negative HCV-RNA results for at least 3 years before screening to be eligible.
History of liver transplantation, on the liver transplantation waiting list, or history of TIPS operation.
Use of anti-obesity drugs within 3 months prior to screening and during the whole trial is prohibited, including bupropion-naltrexone, orlistat, phentermine, phentermine/topiramate and anti-obesity supplements. Subjects planning to receive metabolic bariatric surgery during the study will be excluded (excluding acupuncture weight loss, liposuction or abdominal lipectomy performed more than 1 year before screening).