Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-19 @ 11:23 AM
Study NCT ID:
NCT02585869
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL-C - percent change from baseline', 'timeFrame': '84 days'}], 'secondaryOutcomes': [{'measure': 'Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline', 'timeFrame': '84 days'}, {'measure': 'Adverse Events', 'timeFrame': '84 days'}, {'measure': 'Clinical Laboratory - hematology, chemistry, urinalysis', 'timeFrame': '84 days', 'description': 'Clinical Laboratory Abnormalities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lipid Regulator', 'TG'], 'conditions': ['Hypercholesterolemia', 'Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '12943873', 'type': 'BACKGROUND', 'citation': 'Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or naturally postmenopausal or surgically menopausal women\n* 18 to 80 years of age\n* Baseline HDL-C \\<35 mg/dL (0.9 mmol/L)\n\nExclusion Criteria:\n\n* Creatine phosphokinase (CPK) \\>3 × the upper limit of normal (ULN)\n* Body Mass Index (BMI) \\>35 kg/m2\n* Uncontrolled Hypertension \\>95 mm Hg\n* Uncontrolled diabetes mellitus (HbA1c \\>10%)\n* Renal dysfunction (blood urea nitrogen \\[BUN\\] or creatinine \\>2 × ULN);\n* Hepatic dysfunction (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\] \\>2 × ULN)\n* Uncontrolled hypothyroidism (TSH \\>1.5 × ULN)\n* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months'}, 'identificationModule': {'nctId': 'NCT02585869', 'briefTitle': 'Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroBo Pharmaceuticals Inc.'}, 'officialTitle': 'A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides', 'orgStudyIdInfo': {'id': '1027-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcabene 150 mg', 'description': 'Gemcabene 150 mg once daily (QD)', 'interventionNames': ['Drug: Gemcabene 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 300 mg', 'description': 'Gemcabene 300 mg once daily (QD)', 'interventionNames': ['Drug: Gemcabene 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 600 mg', 'description': 'Gemcabene 600 mg once daily (QD)', 'interventionNames': ['Drug: Gemcabene 600 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 900 mg', 'description': 'Gemcabene 900 mg once daily (QD)', 'interventionNames': ['Drug: Gemcabene 900 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily (QD)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gemcabene 150 mg', 'type': 'DRUG', 'description': 'Blinded capsules and tablets, 150 mg, once daily, 84 days', 'armGroupLabels': ['Gemcabene 150 mg']}, {'name': 'Gemcabene 300 mg', 'type': 'DRUG', 'description': 'Blinded capsules and tablets, 300 mg, once daily, 84 days', 'armGroupLabels': ['Gemcabene 300 mg']}, {'name': 'Gemcabene 600 mg', 'type': 'DRUG', 'description': 'Blinded capsules and tablets, 600 mg, once daily, 84 days', 'armGroupLabels': ['Gemcabene 600 mg']}, {'name': 'Gemcabene 900 mg', 'type': 'DRUG', 'description': 'Blinded capsules and tablets, 900 mg, once daily, 84 days', 'armGroupLabels': ['Gemcabene 900 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Blinded capsule and tablets, once daily, 84 days', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroBo Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}