The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis

Inclusion criteria

• ✓. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.
• ✓. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM).
• ✓. Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.
• ✓. Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or T2DM.
• ✓. In the absence of biopsy, MAFLD-related cirrhosis is defined based on the following criterias:
• ✓. If a participant's MAFLD-related cirrhosis diagnosis for eligibility is based on the biopsy screening period , no weight loss of ≥10% should have occurred in the same time period (based on medical history).