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

Inclusion Criteria:

Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:

NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

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