Dapagliflozin Efficacy and Action in NASH

Prior treatment

• Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
• Participation in other clinical trial in the 30 days before randomization;

Other illness

• A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
• Obstructive biliary disease;
• Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
• A history of Type 1 diabetes;
• A history of bladder cancer;
• Serious medical disease with likely life expectancy less than 5 years;

Lab values

• Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
• Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
• Serum alanine aminotransferase (ALT) greater than 300U/L

Other

• Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
• Women who are pregnant or plan to become pregnant;
• Patients who cannot be followed for 24 months (due to a health situation or migration);
• Patients who are unwilling or unable to give informed consent.

• Men or women aged≥18 years;
• Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
• Patients with T2DM at screening had to have stable glycaemic control (HbA1c \<9.5%) .