A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
NCT ID: NCT01277094
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2011-04-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
RO5093151
Oral daily doses for 12 weeks
2
Placebo
Oral daily doses for 12 weeks
Interventions
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Placebo
Oral daily doses for 12 weeks
RO5093151
Oral daily doses for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Vienna, , Austria
Düsseldorf, , Germany
Nuthetal, , Germany
Tübingen, , Germany
Countries
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References
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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, Haring HU, Furst-Recktenwald S. Inhibition of 11beta-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.
Other Identifiers
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BP25414
Identifier Type: -
Identifier Source: org_study_id