Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT03549260
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-03-24', 'mcpReleaseN': 4, 'releaseDate': '2021-03-01'}, {'resetDate': '2022-02-09', 'mcpReleaseN': 5, 'releaseDate': '2022-01-17'}], 'estimatedResultsFirstSubmitDate': '2021-03-01'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-18', 'size': 1232876, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-05-22T23:11', 'hasProtocol': False}, {'date': '2018-07-24', 'size': 5207951, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-26T11:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in serum LDL-C from baseline after 12 weeks'}], 'secondaryOutcomes': [{'measure': 'The incidence and severity of treatment emergent adverse events (TEAEs)', 'timeFrame': 'baseline to 12 weeks', 'description': 'safety and tolerability will be based on the incidence and severity of treatment emergent adverse events'}, {'measure': 'Percent reduction in apolipoprotein B (Apo B) at week 12', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in serum Apo B from baseline after 12 weeks'}, {'measure': 'Percent reduction in lipoprotein (a) [Lp(a)] at week 12', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in serum Lp(a) from baseline after 12 weeks'}, {'measure': 'Percent reduction in free PCSK9 at week 12', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in serum free PCSK9 from baseline after 12 weeks'}, {'measure': 'Presence of anti LIB003 antibodies (ADAs)', 'timeFrame': 'baseline to 12 weeks', 'description': 'Measurement of ADAs at baseline and various intervals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low density lipoprotein cholesterol', 'PCSK9'], 'conditions': ['LDL Cholesterol']}, 'descriptionModule': {'briefSummary': 'Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy', 'detailedDescription': 'Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18 years of age or older\n2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)\n3. Body mass index (BMI) between 18 and 40 kg/m2\n\nExclusion Criteria:\n\n1. Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening\n2. Homozygous familial hypercholesterolemia\n3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months\n4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment\n5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment\n6. Newly diagnosed or poorly controlled (HbA1c \\>9%) type 2 diabetes\n7. Uncontrolled hypertension\n8. Moderate to severe renal insufficiency\n9. Elevated liver function test at screening\n10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG\n11. A history of prescription drug abuse, illicit drug use, or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT03549260', 'briefTitle': 'Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'LIB Therapeutics LLC'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction', 'orgStudyIdInfo': {'id': 'LIB003-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIB003 150 mg or matching placebo', 'description': 'SC LIB003 150 mg or placebo every 4 weeks', 'interventionNames': ['Biological: LIB003']}, {'type': 'EXPERIMENTAL', 'label': 'LIB003 300 mg or matching placebo', 'description': 'SC LIB003 300 mg or placebo every 4 weeks', 'interventionNames': ['Biological: LIB003']}, {'type': 'EXPERIMENTAL', 'label': 'LIB003 350 mg or matching placebo', 'description': 'SC LIB003 350 mg or placebo every 4 weeks', 'interventionNames': ['Biological: LIB003']}], 'interventions': [{'name': 'LIB003', 'type': 'BIOLOGICAL', 'description': 'LIB003 or placebo', 'armGroupLabels': ['LIB003 150 mg or matching placebo', 'LIB003 300 mg or matching placebo', 'LIB003 350 mg or matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute For Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Louisville Metabolic and Atherosclerosis Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sterling Research Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metabolic & Atherosclerosis Research Center (MARC)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Evan A Stein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LIB Therapeutics LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LIB Therapeutics LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}