Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT03531905
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@esperion.com', 'phone': '1-833-377-7633', 'title': 'Medical Director', 'organization': 'Esperion Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sites 5801003, 5801041, and 5801043 were suspected of Good Clinical Practice violations in an earlier Phase 3 trial (NCT03337308), hence the Efficacy Analysis Set (which excluded these 3 sites) was designated as the primary efficacy analysis set.'}}, 'adverseEventsModule': {'timeFrame': 'up to approximately 16 weeks', 'description': 'Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind investigational medicinal product (IMP) through 30 days after the last dose of double-blind IMP, were collected in members of the Safety Population (all randomized participants who received at least 1 dose of blinded IMP).', 'eventGroups': [{'id': 'EG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 8, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 6, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 7, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}], 'seriousEvents': [{'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.8', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-19.2', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '2.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares (LS) means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.6', 'ciLowerLimit': '-45.8', 'ciUpperLimit': '-33.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.5', 'ciLowerLimit': '-25.7', 'ciUpperLimit': '-13.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.1', 'ciLowerLimit': '-26.2', 'ciUpperLimit': '-14.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set (EAS): all randomized participants who received at least one dose of investigational medicinal product (Full Analysis Set), excluding participants at three study sites. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.2', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.1', 'ciLowerLimit': '-26.2', 'ciUpperLimit': '-14.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.347', 'groupId': 'OG000', 'lowerLimit': '-48.980', 'upperLimit': '3.292'}, {'value': '2.078', 'groupId': 'OG001', 'lowerLimit': '-22.610', 'upperLimit': '48.770'}, {'value': '14.085', 'groupId': 'OG002', 'lowerLimit': '-21.642', 'upperLimit': '50.776'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.7', 'ciLowerLimit': '-55.97', 'ciUpperLimit': '-17.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.77', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.2', 'ciLowerLimit': '-48.92', 'ciUpperLimit': '-9.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.03', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.480', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-30.51', 'ciUpperLimit': '13.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.29', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\\[hsCRP value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.0', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-17.8', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.1', 'ciLowerLimit': '-38.6', 'ciUpperLimit': '-27.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.81', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-9.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.8', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '-12.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[non-HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.3', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.2', 'ciLowerLimit': '-31.7', 'ciUpperLimit': '-22.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.4', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-9.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.9', 'ciLowerLimit': '-18.2', 'ciUpperLimit': '-9.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[TC value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.5', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.91', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.2', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-21.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-18.1', 'ciUpperLimit': '-7.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.4', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '-9.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[apo B value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.20', 'groupId': 'OG000', 'lowerLimit': '-27.97', 'upperLimit': '19.39'}, {'value': '-13.59', 'groupId': 'OG001', 'lowerLimit': '-28.58', 'upperLimit': '1.33'}, {'value': '-5.11', 'groupId': 'OG002', 'lowerLimit': '-19.84', 'upperLimit': '12.15'}]}]}], 'analyses': [{'pValue': '0.457', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-14.55', 'ciUpperLimit': '6.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.44', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-4.93', 'ciUpperLimit': '15.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.068', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-17.92', 'ciUpperLimit': '0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.75', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\\[TG value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.50', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '-3.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.517', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '5.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.118', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.849', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.851', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.667', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Change from Baseline was calculated as the HbA1c value at Week 12 minus the Baseline value. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.877', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.83', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '4.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.83', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.556', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.81', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Percent change from Baseline for HbA1C was analyzed using ANCOVA, with treatment as factor and Baseline HbA1C value as a covariate. Percent change from Baseline for HbA1c was calculated as: (\\[HbA1c value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 12 in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '3.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.589', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '11.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.904', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '9.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.676', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '11.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.66', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for fasting plasma glucose. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for fasting plasma glucose was analyzed using ANCOVA, with treatment as factor and Baseline fasting plasma glucose as a covariate. Percent change from Baseline for fasting plasma glucose was calculated as: (\\[fasting plasma glucose value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For fasting plasma glucose, if a measured fasting plasma glucose value was available, measured fasting plasma glucose was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '24.25', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '31.88', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '25.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn 2 hours ± 5 minutes after the start of the meal. Samples were collected and analyzed for PPG. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for PPG was calculated as: (\\[PPG value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For PPG, if a measured PPG value was available, measured PPG was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '9.59', 'groupId': 'OG001'}, {'value': '18.9', 'spread': '9.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.258', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.8', 'ciLowerLimit': '-43.4', 'ciUpperLimit': '11.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '27.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.79', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.235', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.3', 'ciLowerLimit': '-43.3', 'ciUpperLimit': '10.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'The HOMA-IR index was calculated from the fasting glucose and insulin values that were obtained at each clinic visit (Day 1/Visit T1, Week 4/Visit T2, and Week 12/Visit T3) during the double-blind treatment period, using the formula: (fasting glucose \\[millimoles per milliliter {mmol/ml}\\] x fasting insulin \\[micro International Units per milliliter {μIU/ml}\\]) divided by 22.5. Percent change from Baseline for HOMA-IR index was analyzed using ANCOVA, with treatment as factor and Baseline HOMA-IR index as a covariate. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for HOMA-IR index was calculated as: (\\[HOMA-IR index value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to approximately 16 weeks', 'description': 'Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind IMP through 30 days after the last dose of double-blind IMP. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, including control, and which does not necessarily have a causal relationship with treatment. An AE is: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (e.g., electrocardiogram or x-ray) that results in symptoms, a change in treatment, or discontinuation from IMP; or an adverse drug reaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received at least one dose of IMP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant was out of town', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Could not speak with the participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.3', 'spread': '8.65', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '8.00', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '8.63', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '8.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '145.06', 'spread': '31.504', 'groupId': 'BG000'}, {'value': '139.24', 'spread': '28.121', 'groupId': 'BG001'}, {'value': '143.36', 'spread': '26.421', 'groupId': 'BG002'}, {'value': '142.55', 'spread': '28.715', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the average of Screening Visit 3 (Visit S3) and Treatment Visit 1 (Visit T1) values (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set: all randomized participants who received at least one dose of investigational medicinal product (Full Analysis Set), excluding participants at 3 study sites'}, {'title': 'High-sensitivity C-reactive protein (hsCRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.570', 'groupId': 'BG000', 'lowerLimit': '1.735', 'upperLimit': '4.860'}, {'value': '2.420', 'groupId': 'BG001', 'lowerLimit': '1.545', 'upperLimit': '5.590'}, {'value': '3.480', 'groupId': 'BG002', 'lowerLimit': '1.520', 'upperLimit': '8.040'}, {'value': '2.610', 'groupId': 'BG003', 'lowerLimit': '1.550', 'upperLimit': '5.740'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP).', 'unitOfMeasure': 'milligrams per liter (mg/ L)', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Non-high-density lipoprotein cholesterol (non-HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '181.69', 'spread': '36.659', 'groupId': 'BG000'}, {'value': '172.87', 'spread': '33.277', 'groupId': 'BG001'}, {'value': '177.38', 'spread': '29.116', 'groupId': 'BG002'}, {'value': '177.31', 'spread': '33.194', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the average of Visit S3 and Visit T1 values (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Total cholesterol (TC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '230.34', 'spread': '37.234', 'groupId': 'BG000'}, {'value': '221.33', 'spread': '33.592', 'groupId': 'BG001'}, {'value': '225.94', 'spread': '32.830', 'groupId': 'BG002'}, {'value': '225.87', 'spread': '34.619', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the average of Visit S3 and Visit T1 values (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Apolipoprotein B (Apo B)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '121.6', 'spread': '22.95', 'groupId': 'BG000'}, {'value': '117.3', 'spread': '22.96', 'groupId': 'BG001'}, {'value': '120.8', 'spread': '18.53', 'groupId': 'BG002'}, {'value': '119.9', 'spread': '21.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the last value prior to the first dose of IMP.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Triglycerides (TGs)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '172.25', 'groupId': 'BG000', 'lowerLimit': '127.50', 'upperLimit': '238.50'}, {'value': '159.25', 'groupId': 'BG001', 'lowerLimit': '118.25', 'upperLimit': '236.50'}, {'value': '163.00', 'groupId': 'BG002', 'lowerLimit': '124.50', 'upperLimit': '219.50'}, {'value': '163.00', 'groupId': 'BG003', 'lowerLimit': '121.00', 'upperLimit': '232.50'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline was defined as the average of Visit S3 and Visit T1 values (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'High-density lipoprotein cholesterol (HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '48.73', 'spread': '13.067', 'groupId': 'BG000'}, {'value': '47.95', 'spread': '10.847', 'groupId': 'BG001'}, {'value': '48.53', 'spread': '13.482', 'groupId': 'BG002'}, {'value': '48.40', 'spread': '12.447', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the average of Visit S3 and Visit T1 values (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Hemoglobin A1C (HbA1c)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.86', 'spread': '0.927', 'groupId': 'BG000'}, {'value': '7.96', 'spread': '1.279', 'groupId': 'BG001'}, {'value': '8.02', 'spread': '0.773', 'groupId': 'BG002'}, {'value': '7.95', 'spread': '1.013', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the last value prior to the first dose of IMP.', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'Fasting plasma glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '162.4', 'spread': '46.10', 'groupId': 'BG000'}, {'value': '153.3', 'spread': '46.73', 'groupId': 'BG001'}, {'value': '174.2', 'spread': '57.53', 'groupId': 'BG002'}, {'value': '163.2', 'spread': '50.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the last value prior to the first dose of IMP.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}, {'title': 'HOMA-IR index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.709', 'spread': '6.200', 'groupId': 'BG000'}, {'value': '10.847', 'spread': '18.074', 'groupId': 'BG001'}, {'value': '13.267', 'spread': '21.305', 'groupId': 'BG002'}, {'value': '10.199', 'spread': '16.503', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Normal HOMA-IR values range from 0.5 to 1.4. A value less than 1.0 indicates insulin sensitivity. A value above 1.9 indicates early insulin resistance. A value above 2.9 indicates significant insulin resistance. A higher number indicates increased insulin resistance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Efficacy Analysis Set'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-14', 'size': 1540230, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-16T12:09', 'hasProtocol': True}, {'date': '2019-07-23', 'size': 366518, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-16T12:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2018-05-09', 'resultsFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-08', 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Fasting Plasma Glucose', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for fasting plasma glucose. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for fasting plasma glucose was analyzed using ANCOVA, with treatment as factor and Baseline fasting plasma glucose as a covariate. Percent change from Baseline for fasting plasma glucose was calculated as: (\\[fasting plasma glucose value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For fasting plasma glucose, if a measured fasting plasma glucose value was available, measured fasting plasma glucose was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn 2 hours ± 5 minutes after the start of the meal. Samples were collected and analyzed for PPG. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for PPG was calculated as: (\\[PPG value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For PPG, if a measured PPG value was available, measured PPG was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index', 'timeFrame': 'Baseline; Week 12', 'description': 'The HOMA-IR index was calculated from the fasting glucose and insulin values that were obtained at each clinic visit (Day 1/Visit T1, Week 4/Visit T2, and Week 12/Visit T3) during the double-blind treatment period, using the formula: (fasting glucose \\[millimoles per milliliter {mmol/ml}\\] x fasting insulin \\[micro International Units per milliliter {μIU/ml}\\]) divided by 22.5. Percent change from Baseline for HOMA-IR index was analyzed using ANCOVA, with treatment as factor and Baseline HOMA-IR index as a covariate. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for HOMA-IR index was calculated as: (\\[HOMA-IR index value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to approximately 16 weeks', 'description': 'Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind IMP through 30 days after the last dose of double-blind IMP. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, including control, and which does not necessarily have a causal relationship with treatment. An AE is: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (e.g., electrocardiogram or x-ray) that results in symptoms, a change in treatment, or discontinuation from IMP; or an adverse drug reaction.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\\[hsCRP value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[non-HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[TC value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[apo B value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\\[TG value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\\[HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used.'}, {'measure': 'Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12', 'timeFrame': 'Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.'}, {'measure': 'Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.'}, {'measure': 'Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Change from Baseline was calculated as the HbA1c value at Week 12 minus the Baseline value. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.'}, {'measure': 'Percent Change From Baseline to Week 12 in HbA1c', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Percent change from Baseline for HbA1C was analyzed using ANCOVA, with treatment as factor and Baseline HbA1C value as a covariate. Percent change from Baseline for HbA1c was calculated as: (\\[HbA1c value at Week 12 minus Baseline value\\] divided by \\[Baseline value\\]) multiplied by 100. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'cholesterolemia', 'type 2 diabetes', 'LDL-C', 'T2D', 'diabetes mellitus'], 'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2', 'Cholesterolemia']}, 'referencesModule': {'references': [{'pmid': '24385236', 'type': 'BACKGROUND', 'citation': 'Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.'}]}, 'descriptionModule': {'briefSummary': '12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C', 'detailedDescription': 'Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for 6 months or greater\n* Currently taking stable diabetes medication for 3 months or greater\n* HbA1c between 7-10%\n* LDL-cholesterol greater than 70 mg/dL\n* Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication\n\nExclusion Criteria:\n\n* Body mass index \\> 40 kg/m2\n* History of documented clinically significant cardiovascular disease\n* Fasting triglycerides \\> 400 mg/dL\n* History of Type 1 diabetes\n* Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy\n* History of drug or alcohol abuse within 2 years'}, 'identificationModule': {'nctId': 'NCT03531905', 'briefTitle': 'Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol', 'orgStudyIdInfo': {'id': '1002FDC-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bempedoic acid + Ezetimibe FDC', 'description': 'Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule', 'interventionNames': ['Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet', 'Drug: Placebo oral capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe 10 mg', 'description': 'Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet', 'interventionNames': ['Drug: Ezetimibe 10 mg Oral Tablet', 'Drug: Placebo Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Oral Tablet, Placebo oral capsule', 'interventionNames': ['Drug: Placebo Oral Tablet', 'Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Bempedoic acid + Ezetimibe FDC Oral Tablet', 'type': 'DRUG', 'description': 'Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet', 'armGroupLabels': ['Bempedoic acid + Ezetimibe FDC']}, {'name': 'Ezetimibe 10 mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Zetia'], 'description': 'Ezetimibe 10 mg tablet, overencapsulated for blinding purposes', 'armGroupLabels': ['Ezetimibe 10 mg']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo tablet, matched for the FDC product for blinding purposes', 'armGroupLabels': ['Ezetimibe 10 mg', 'Placebo']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo over-encapsulated for blinding purposes', 'armGroupLabels': ['Bempedoic acid + Ezetimibe FDC', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'FInlay Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-MARC Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '23435', 'city': 'Suffolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Center for Clinical Research', 'geoPoint': {'lat': 36.72836, 'lon': -76.58496}}], 'overallOfficials': [{'name': 'Ron Haberman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Esperion Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}