Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-04-22 @ 10:39 PM
Study NCT ID:
NCT02586168
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111024', 'term': 'gemcabene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2001-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '4 weeks'}, {'measure': 'ECG', 'timeFrame': '4 weeks', 'description': 'Clinically Significant Changes'}, {'measure': 'Clinical Laboratory - hematology, chemistry', 'timeFrame': '4 weeks', 'description': 'Clinical Laboratory Abnormalities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin Resistance', 'Lipid Regulator'], 'conditions': ['Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments\n* Males; and females of non-reproductive potential\n* Obesity\n* Non-diabetic\n\nExclusion Criteria:\n\n* Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.\n* Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening\n* Use of any anti-diabetic medications\n* Use of any steroid medications\n* Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1\n* If female, pregnant, lactating or of childbearing potential; and\n* History of significant reaction to any fibrate lipid-lowering agent'}, 'identificationModule': {'nctId': 'NCT02586168', 'briefTitle': 'The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroBo Pharmaceuticals Inc.'}, 'officialTitle': 'The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects', 'orgStudyIdInfo': {'id': '1027-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcabene 900 mg', 'description': 'Gemcabene 900 mg', 'interventionNames': ['Drug: Gemcabene 900 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gemcabene 900 mg', 'type': 'DRUG', 'description': 'Gemcabene 900 mg once daily (QD)', 'armGroupLabels': ['Gemcabene 900 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroBo Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}