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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: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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: RO5093151
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277094

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01277094     History of Changes
Other Study ID Numbers: BP25414
Study First Received: January 13, 2011
Last Updated: October 10, 2012
Health Authority: Austria: Ministry of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013