Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients

Inclusion Criteria:

EITHER

-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before
randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological
diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L
(males) or greater than or equal to 35 IU/L (females) at screening.

OR

Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:

- ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L
(females) AND

- BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other
than Asian) or greater than or equal to 23 kg/m^2 (in patients with a self identified
Asian race) AND

- Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and
less than or equal to 10%

- Patients must weigh no more than 150 kg (330 lbs) to participate in the study.

- Male and female patients 18 years or older at the time of screening visit.

Exclusion Criteria:

- History or presence of other concomitant liver diseases

- History or current diagnosis of ECG abnormalities

- Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically
active weight loss drugs within 6 weeks of screening and until end of study

- Patients with contraindications to MRI imaging

- Current or history of significant alcohol consumption

- Clinical evidence of hepatic decompensation or severe liver impairment

- Women of child bearing potential (unless on basic contraception methods)

- Presence of liver cirrhosis