Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-02 @ 4:09 AM
Study NCT ID:
NCT00596934
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C415771', 'term': 'metreleptin'}, {'id': 'C122136', 'term': 'recombinant methionyl human leptin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eliforal@med.umich.edu', 'phone': '734-615-7271', 'title': 'Dr. Elif A. Oral', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a non-blinded, non-placebo controlled proof of concept trial. Out of the 9 patients, there were 7 completers.'}}, 'adverseEventsModule': {'timeFrame': '13 months from patient baseline appointment.', 'description': "Adverse event data collected from patient's baseline study appointment till one month following patient's 12 month study appointment.", 'eventGroups': [{'id': 'EG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'left side muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'actinic keratoses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rectal pressure with ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'right sternocleidomastoid lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'right axilla lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'toxoplasmosis', 'notes': 'add description of advent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '1.73', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000'], 'groupDescription': 'Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who completed the year of metreleptin treatment and had follow-up liver biopsies after one year.'}, {'type': 'SECONDARY', 'title': 'Body Weight at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin: 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'spread': '9.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that completed 12 months of metreleptin treatment.'}, {'type': 'SECONDARY', 'title': 'Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '9.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000'], 'pValueComment': 'p = 0.074', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs') fractional fat content throughout the liver in a few breath-hold intervals.", 'unitOfMeasure': 'liver fat percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '29.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'ALT value in subjects that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects who completed 12 months of metreleptin treatment.'}, {'type': 'SECONDARY', 'title': 'Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Group', 'description': 'Treatment group\n\nmetreleptin: 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'AST value in subjects that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects who completed 12 months of metreleptin treatment.'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose Value at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '5.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Fasting glucose value in subjects that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects who completed 12 months of metreleptin treatment.'}, {'type': 'SECONDARY', 'title': 'Fasting Triglycerides Value at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '146.4', 'spread': '75.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000'], 'pValueComment': 'p-value = 0.195.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects who completed 12 months of metreleptin treatment.'}, {'type': 'SECONDARY', 'title': 'Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'HOMA values in subjects that completed 12 months of metreleptin treatment.', 'unitOfMeasure': 'mU/L x mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects who completed 12 months of metreleptin treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NASH02', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred from February 2007 and concluded in October 2007.', 'preAssignmentDetails': 'One of ten enrolled participants screen failed during baseline visit, liver biopsy showed no non-alcoholic steatohepatitis. Therefore he is not included in any tables or analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Metreleptin Treatment Arm', 'description': 'Treatment group\n\nmetreleptin : 0.1 mg/kg/day once a day via subcutaneous injections'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '53'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Non-alcoholic steatohepatitis (NASH) score', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'NASH scale: 0 - 14. The higher the NASH score the more severe the liver disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver fat percentage by Magnetic Resonance Imaging (MRI - Dixon method)', 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs') fractional fat content throughout the liver in a few breath-hold intervals.", 'unitOfMeasure': 'liver fat percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver function test: Alanine aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '19.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Normal range for laboratory values: \\<=35 IU/L', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver function test: Aspartate aminotransferase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Normal range for laboratory values: 8 - 30 IU/L', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Normal range for laboratory values: 73 - 100 mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin Resistance: homeostatic model assessment (HOMA)', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '3.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HOMA values are based on fasting insulin and glucose concentrations and calculated as fasting insulin concentration (mU/L) x fasting glucose concentration (mg/dL)/405', 'unitOfMeasure': 'mU/L x mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '129.4', 'spread': '66.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Normal range for laboratory values: \\<150 mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2008-01-08', 'resultsFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-17', 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months', 'timeFrame': '1 year', 'description': 'Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.'}], 'secondaryOutcomes': [{'measure': 'Body Weight at 12 Months', 'timeFrame': '1 year', 'description': 'Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.'}, {'measure': 'Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months', 'timeFrame': '1 year', 'description': "For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs') fractional fat content throughout the liver in a few breath-hold intervals."}, {'measure': 'Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months', 'timeFrame': '1 year', 'description': 'ALT value in subjects that completed 12 months of metreleptin treatment.'}, {'measure': 'Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months', 'timeFrame': '1 year', 'description': 'AST value in subjects that completed 12 months of metreleptin treatment.'}, {'measure': 'Fasting Glucose Value at 12 Months', 'timeFrame': '1 year', 'description': 'Fasting glucose value in subjects that completed 12 months of metreleptin treatment.'}, {'measure': 'Fasting Triglycerides Value at 12 Months', 'timeFrame': '1 year', 'description': 'Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.'}, {'measure': 'Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months', 'timeFrame': '1 year', 'description': 'HOMA values in subjects that completed 12 months of metreleptin treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nonalcoholic fatty liver disease', 'Insulin resistance', 'Obesity', 'Leptin therapy', 'NASH'], 'conditions': ['Fatty Liver Disease, Nonalcoholic']}, 'referencesModule': {'references': [{'pmid': '35291351', 'type': 'DERIVED', 'citation': 'Akinci B, Subauste A, Ajluni N, Esfandiari NH, Meral R, Neidert AH, Eraslan A, Hench R, Rus D, McKenna B, Hussain HK, Chenevert TL, Tayeh MK, Rupani AR, Innis JW, Mantzoros CS, Conjeevaram HS, Burant CL, Oral EA. Metreleptin therapy for nonalcoholic steatohepatitis: Open-label therapy interventions in two different clinical settings. Med. 2021 Jul 9;2(7):814-835. doi: 10.1016/j.medj.2021.04.001. Epub 2021 May 12.'}], 'seeAlsoLinks': [{'url': 'http://www.uofmhealth.org/profile/83/elif-oral-md', 'label': 'PIs Web site'}]}, 'descriptionModule': {'briefSummary': 'Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone called leptin. Recently, we have learned that obese or overweight persons make too much leptin, which may contribute to insulin resistance. Paradoxically, patients who do not have any fat cells, also have insulin resistance. In these patients, insulin resistance is caused by the absence of leptin and leptin replacement significantly improves insulin resistance and fat deposition in the liver. In an earlier study, we determined the leptin levels in patients with NASH and how these levels are related to body fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH have relatively low levels of leptin in contrast to the amount of body fat they had. We now would like to see if restoring leptin levels to normal will improve the disease process in these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive), who do not have any other cause for their liver disease. We have put some restrictions in body size such that a spectrum of patients from normal weight to obese range would be included. They will also demonstrate low leptin levels (levels similar to only 25% of normal population). We will use a genetically engineered form of leptin manufactured by Amylin Inc. given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters and body composition characteristics that we examined in our earlier study. We expect that patients with low blood leptin levels will show improvement in their liver disease and insulin resistance when their blood leptin levels are restored to normal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven NASH\n* Circulating fasting leptin \\<9 ng/mL (staggered criteria for different BMI levels)\n\nExclusion Criteria:\n\n* Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal prothrombin time or albumin)\n* Presence of clinical lipodystrophy\n* Presence of other liver disease\n* Presence of clinical diabetes (fasting \\>126 mg/dL or 2 hour post 75 g-glucose \\>200 mg/dL or random glucose \\>200 mg/dL with presence of diabetes symptoms or known history of diabetes)\n* Any medication for treatment of NASH or obesity\n* Presence of HIV\n* Inability to give informed consent\n* Presence of end-stage renal disease, any type of active cancer, or \\>class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination\n* Presence of any other condition that limits life expectancy to \\<2 years\n* Active infection (may be transient)\n* Any other condition in the opinion of the investigators that may impede successful data collection'}, 'identificationModule': {'nctId': 'NCT00596934', 'briefTitle': 'Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Nonalcoholic Steatohepatitis: is Leptin an Etiological Factor (Phase 2).', 'orgStudyIdInfo': {'id': 'R03DK074488', 'link': 'https://reporter.nih.gov/quickSearch/R03DK074488', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R03DK074488', 'link': 'https://reporter.nih.gov/quickSearch/R03DK074488', 'type': 'NIH'}, {'id': 'Protocol 2145 (MCRU)'}, {'id': 'Amylin Protocol 20050119'}, {'id': 'DRDA 643938K3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metreleptin treatment group', 'description': 'Treatment group', 'interventionNames': ['Drug: metreleptin']}], 'interventions': [{'name': 'metreleptin', 'type': 'DRUG', 'otherNames': ['(originally A100, recombinant-human-Methionyl-leptin'], 'description': '0.1 mg/kg/day once a day via subcutaneous injections', 'armGroupLabels': ['Metreleptin treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Elif A Oral, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elif Oral', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Prof of Medicine', 'investigatorFullName': 'Elif Oral', 'investigatorAffiliation': 'University of Michigan'}}}}