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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 13, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD Drug: Placebo Drug: RO5093151 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change of liver fat content measured by magnetic resonance spectroscopy (MRS) [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp [ Time Frame: Week 12 ]
  • Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp [ Time Frame: Week 12 ]
  • Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) [ Time Frame: Week 12 ]
  • Safety (incidence and nature of adverse events) [ Time Frame: Week 12 ]

Enrollment: 82
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5093151
Oral daily doses for 12 weeks
Placebo Comparator: 2 Drug: Placebo
Oral daily doses for 12 weeks


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01277094

Wien, Austria, 1090
Dusseldorf, Germany, 40225
Nuthetal, Germany, 14558
Tübingen, Germany, 72076
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01277094     History of Changes
Other Study ID Numbers: BP25414
Study First Received: January 13, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases processed this record on September 21, 2017