Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT01277094
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-01-13', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of liver fat content measured by magnetic resonance spectroscopy (MRS)', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp', 'timeFrame': 'Week 12'}, {'measure': 'Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp', 'timeFrame': 'Week 12'}, {'measure': 'Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)', 'timeFrame': 'Week 12'}, {'measure': 'Safety (incidence and nature of adverse events)', 'timeFrame': 'Week 12'}]}, 'conditionsModule': {'conditions': ['Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD']}, 'referencesModule': {'references': [{'pmid': '24795254', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, 35-65 years of age\n* Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat \\>5.56% at screening\n* Body mass index (BMI) \\>27 kg/m2 at screening\n* Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) \\> 2.5 at screening\n* Agreement to maintain prior diet and exercise habits during the full course of study\n\nExclusion Criteria:\n\n* History of diabetes mellitus based on World Health Organization (WHO) criteria\n* Known polycystic ovary syndrome\n* Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis\n* Known autoimmune disease or chronic inflammatory disease\n* Myocardial infarction or stroke within 6 months prior to screening\n* Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening'}, 'identificationModule': {'nctId': 'NCT01277094', 'briefTitle': 'A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'BP25414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RO5093151']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral daily doses for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'RO5093151', 'type': 'DRUG', 'description': 'Oral daily doses for 12 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '14558', 'city': 'Nuthetal', 'country': 'Germany'}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}