Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

Inclusion Criteria:

- Male/female patients, 18 years or older

- Written informed consent

- Presence of NASH by histologic evidence (liver biopsy) and elevated alanine
aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and
diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

- Current use of obeticholic acid (OCA)

- New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide,
albiglutide or dulaglutide within 3 months of screening

- Pregnant or nursing (lactating) women

- Women of child-bearing potential, unless they are using highly effective methods of
contraception during dosing and for 5 days after stopping study medication

- Current or history of significant alcohol consumption for a period of more than 3
consecutive months within 1 year prior to screening

- Clinical evidence of hepatic decompensation or severe liver impairment

- Previous diagnosis of other forms of chronic liver disease

- Uncontrolled diabetes mellitus

- History or current diagnosis of ECG abnormalities

- Patients with contraindications to MRI imaging