A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

Multi-center, Double-blind, Randomized, Placebo-controlled Study of Selective 11 Beta-HSD1 Inhibition With RO5093151 for 12 Weeks to Investigate Efficacy, Safety and Pharmacokinetics of RO5093151 in Non-alcoholic Fatty Liver Disease and Its Metabolic Consequences.

This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.

Inclusion Criteria:

• Adult patients, 35-65 years of age
• Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat >5.56% at screening
• Body mass index (BMI) >27 kg/m2 at screening
• Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) > 2.5 at screening
• Agreement to maintain prior diet and exercise habits during the full course of study

Exclusion Criteria:

• History of diabetes mellitus based on World Health Organization (WHO) criteria
• Known polycystic ovary syndrome
• Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis
• Known autoimmune disease or chronic inflammatory disease
• Myocardial infarction or stroke within 6 months prior to screening
• Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening