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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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