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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277094
Recruitment Status : Completed
First Posted : January 14, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

January 13, 2011
January 14, 2011
November 2, 2016
April 2011
March 2012   (Final data collection date for primary outcome measure)
Change of liver fat content measured by magnetic resonance spectroscopy (MRS) [ Time Frame: Week 12 ]
Same as current
Complete list of historical versions of study NCT01277094 on Archive Site
  • 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 ]
Same as current
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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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
  • Drug: Placebo
    Oral daily doses for 12 weeks
  • Drug: RO5093151
    Oral daily doses for 12 weeks
  • Experimental: 1
    Intervention: Drug: RO5093151
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Stefan N, Ramsauer M, Jordan P, Nowotny B, Kantartzis K, Machann J, Hwang JH, Nowotny P, Kahl S, Harreiter J, Hornemann S, Sanyal AJ, Stewart PM, Pfeiffer AF, Kautzky-Willer A, Roden M, Häring HU, Fürst-Recktenwald S. Inhibition of 11β-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):406-16. doi: 10.1016/S2213-8587(13)70170-0. Epub 2014 Feb 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP