Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 8:17 PM
Study NCT ID:
NCT01723735
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
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': 'C571059', 'term': 'alirocumab'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the effect of alirocumab on LDL-C', 'timeFrame': 'Up to 18 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of the pharmacodynamic profile of alirocumab', 'timeFrame': 'Up to 18 weeks'}, {'measure': 'Pharmacokinetics: Assessment of serum concentrations of alirocumab', 'timeFrame': 'Up to 18 weeks'}, {'measure': 'Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)', 'timeFrame': 'Up to 18 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '27287699', 'type': 'RESULT', 'citation': 'Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).\n\nSecondary Objectives:\n\n* To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.\n* To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.', 'detailedDescription': 'Total duration of the study per subject (excluding screening) is about 22 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Healthy male /or female subjects,\n* aged 18 to 65 years old,\n* with LDL-C \\> 130 mg/dL\n* not receiving lipid lowering therapy.\n\nExclusion criteria:\n\n* Healthy subjects with history or presence of clinically relevant illness.\n* Subjects currently taking statins, ezetimibe or fenofibrate.\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01723735', 'briefTitle': 'Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PKD12910'}, 'secondaryIdInfos': [{'id': 'U1111-1131-3203', 'type': 'OTHER', 'domain': 'UTN'}, {'id': '2012-003049-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab + Ezetimibe Placebo', 'description': 'Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo', 'interventionNames': ['Drug: Alirocumab', 'Drug: Ezetimibe Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Alirocumab + Ezetimibe', 'description': 'Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe', 'interventionNames': ['Drug: Alirocumab', 'Drug: Ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': 'Alirocumab + Fenofibrate', 'description': 'Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate', 'interventionNames': ['Drug: Alirocumab', 'Drug: Fenofibrate']}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'otherNames': ['SAR236553', 'REGN727'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Alirocumab + Ezetimibe', 'Alirocumab + Ezetimibe Placebo', 'Alirocumab + Fenofibrate']}, {'name': 'Ezetimibe', 'type': 'DRUG', 'description': 'Pharmaceutical form: overencapsulated tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Alirocumab + Ezetimibe']}, {'name': 'Ezetimibe Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: capsule\n\nRoute of administration: oral', 'armGroupLabels': ['Alirocumab + Ezetimibe Placebo']}, {'name': 'Fenofibrate', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Alirocumab + Fenofibrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Investigational Site Number 250001', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '92502', 'city': 'Rueil-Malmaison', 'country': 'France', 'facility': 'Investigational Site Number 250002', 'geoPoint': {'lat': 48.8765, 'lon': 2.18967}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}