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Trial record 47 of 345 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
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.
Study Start Date : April 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: 1 Drug: RO5093151
Oral daily doses for 12 weeks

Placebo Comparator: 2 Drug: Placebo
Oral daily doses for 12 weeks

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01277094

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT01277094     History of Changes
Other Study ID Numbers: BP25414
First Posted: January 14, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases