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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01277094
First received: January 13, 2011
Last updated: August 4, 2014
Last verified: August 2014

January 13, 2011
August 4, 2014
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01277094 on ClinicalTrials.gov Archive Site
  • Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Pharmacokinetic measures (max and min concentration, clearance, half-life, etc) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Safety (incidence and nature of adverse events) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 evalu ate 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 anticipat ed time on study treatment is 12 weeks.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
  • Drug: RO5093151
    Oral daily doses for 12 weeks
  • Drug: Placebo
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
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
Both
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT01277094
BP25414
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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