Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

Exclusion Criteria

• •Type 1 diabetes mellitus
• •Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening
• •HbA1c \< 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
• •Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
• •* Platelet count \< LLN (see Central laboratory manual).
• •* Serum albumin \< LLN (see Central laboratory manual).
• •* International Normalized Ratio (INR) \> ULN (see Central laboratory manual).
• •* ALT or AST \> 5× ULN (confirmed by 2 values during screening).
• •* Total bilirubin \> ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
• •* Alkaline phosphatase \> 300 IU/L (confirmed by 2 values during screening).
• •* History of esophageal varices, ascites or hepatic encephalopathy
• •* Splenomegaly
• •* MELD score \>12