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

Phase 1

Completed

• Conditions: Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
• Interventions: Drug: RO5093151; Drug: Placebo

• Registration Number: NCT01277094
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	RO5093151	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)	Week 12

Secondary Outcome Measures

Name	Time	Method
Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp	Week 12
Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp	Week 12
Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)	Week 12
Safety (incidence and nature of adverse events)	Week 12