Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT02571257
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C - percent change from baseline at Week 8', 'timeFrame': '56 days'}], 'secondaryOutcomes': [{'measure': 'Plasma lipid levels - percent change from baseline at Week 8', 'timeFrame': '56 days', 'description': 'apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)'}, {'measure': 'Adverse Events', 'timeFrame': '56 days'}, {'measure': 'Clinical Laboratory', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LDL-C', 'Lipid Regulator'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '27678439', 'type': 'DERIVED', 'citation': 'Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females\n* 18 to 65 years of age\n* Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)\n\nExclusion Criteria:\n\n* If female, postmenopausal or surgically menopausal\n* Triglycerides (TG) \\>400 mg/dL\n* Creatine phosphokinase (CPK) \\>3 × the upper limit of normal (ULN)\n* Body Mass Index (BMI) \\>35 kg/m2\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* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month'}, 'identificationModule': {'nctId': 'NCT02571257', 'briefTitle': 'Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroBo Pharmaceuticals Inc.'}, 'officialTitle': 'An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin', 'orgStudyIdInfo': {'id': '1027-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment on stable background statin therapy', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 300 mg QD', 'description': 'Gemcabene (also known as CI-1027) treatment on stable background statin therapy', 'interventionNames': ['Drug: Gemcabene']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 900 mg QD', 'description': 'Gemcabene (also known as CI-1027) treatment on stable background statin therapy', 'interventionNames': ['Drug: Gemcabene']}], 'interventions': [{'name': 'Gemcabene', 'type': 'DRUG', 'description': '1-300 mg tablet, QD, 56 days', 'armGroupLabels': ['Gemcabene 300 mg QD']}, {'name': 'Gemcabene', 'type': 'DRUG', 'description': '3-300 mg tablets, QD, 56 days', 'armGroupLabels': ['Gemcabene 900 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroBo Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}