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

Roche

Status and phase

Completed

Phase 1

Conditions

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Treatments

Drug: RO5093151

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01277094

BP25414

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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