Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01890967
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY3015014 in Participants With High Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000610655', 'term': 'frovocimab'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D000077340', 'term': 'Fluvastatin'}, {'id': 'C108475', 'term': 'pitavastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Participants at Risk included all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 87, 'otherNumAffected': 63, 'seriousNumAtRisk': 87, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 87, 'otherNumAffected': 69, 'seriousNumAtRisk': 87, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 86, 'otherNumAffected': 64, 'seriousNumAtRisk': 86, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 86, 'otherNumAffected': 64, 'seriousNumAtRisk': 86, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 86, 'otherNumAffected': 64, 'seriousNumAtRisk': 86, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'otherNumAtRisk': 87, 'otherNumAffected': 58, 'seriousNumAtRisk': 87, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '-40.5', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-50.5', 'spread': '2.30', 'groupId': 'OG003'}, {'value': '-14.9', 'spread': '2.35', 'groupId': 'OG004'}, {'value': '-37.1', 'spread': '2.44', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'title': 'LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '-46.4', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '-56.5', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '-18.4', 'spread': '2.14', 'groupId': 'OG004'}, {'value': '-42.2', 'spread': '2.21', 'groupId': 'OG005'}]}]}, {'title': 'TG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '3.35', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '3.25', 'groupId': 'OG002'}, {'value': '-15.1', 'spread': '3.26', 'groupId': 'OG003'}, {'value': '-7.2', 'spread': '3.29', 'groupId': 'OG004'}, {'value': '-10.6', 'spread': '3.35', 'groupId': 'OG005'}]}]}, {'title': 'TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '-27.8', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '-34.1', 'spread': '1.44', 'groupId': 'OG003'}, {'value': '-11.0', 'spread': '1.45', 'groupId': 'OG004'}, {'value': '-24.6', 'spread': '1.48', 'groupId': 'OG005'}]}]}, {'title': 'HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '1.58', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '1.59', 'groupId': 'OG004'}, {'value': '8.4', 'spread': '1.61', 'groupId': 'OG005'}]}]}, {'title': 'Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '-39.3', 'spread': '1.83', 'groupId': 'OG002'}, {'value': '-48.9', 'spread': '1.83', 'groupId': 'OG003'}, {'value': '-16.1', 'spread': '1.84', 'groupId': 'OG004'}, {'value': '-35.8', 'spread': '1.88', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'title': 'Apo A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '1.41', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '1.43', 'groupId': 'OG004'}, {'value': '5.8', 'spread': '1.44', 'groupId': 'OG005'}]}]}, {'title': 'Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '-34.9', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '-46.8', 'spread': '2.25', 'groupId': 'OG003'}, {'value': '-16.0', 'spread': '2.25', 'groupId': 'OG004'}, {'value': '-31.9', 'spread': '2.31', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.0436', 'groupId': 'OG000'}, {'value': '-16.63', 'spread': '0.0442', 'groupId': 'OG001'}, {'value': '-19.02', 'spread': '0.0427', 'groupId': 'OG002'}, {'value': '-37.29', 'spread': '0.0420', 'groupId': 'OG003'}, {'value': '-7.54', 'spread': '0.0427', 'groupId': 'OG004'}, {'value': '-21.01', 'spread': '0.0437', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.70', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.70', 'groupId': 'OG004'}, {'value': '-0.7', 'spread': '0.72', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '13.66', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '14.00', 'groupId': 'OG001'}, {'value': '86.4', 'spread': '13.65', 'groupId': 'OG002'}, {'value': '130.6', 'spread': '13.63', 'groupId': 'OG003'}, {'value': '21.8', 'spread': '13.63', 'groupId': 'OG004'}, {'value': '41.0', 'spread': '13.63', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '5.81', 'groupId': 'OG001'}, {'value': '-36.6', 'spread': '5.67', 'groupId': 'OG002'}, {'value': '-68.0', 'spread': '5.71', 'groupId': 'OG003'}, {'value': '-4.4', 'spread': '5.80', 'groupId': 'OG004'}, {'value': '-35.2', 'spread': '5.72', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '1590', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '9670', 'spread': '29.9', 'groupId': 'OG001'}, {'value': '27300', 'spread': '26.3', 'groupId': 'OG002'}, {'value': '7800', 'spread': '28.5', 'groupId': 'OG003'}, {'value': '26600', 'spread': '32.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose', 'unitOfMeasure': 'μg∙hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomly assigned participants who received at least one dose of the study medication and had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Injection Site Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'OG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Q4W', 'description': 'Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'FG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'FG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'FG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'FG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'FG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '88'}, {'groupId': 'FG004', 'numSubjects': '87'}, {'groupId': 'FG005', 'numSubjects': '88'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '86'}, {'groupId': 'FG004', 'numSubjects': '86'}, {'groupId': 'FG005', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '77'}, {'groupId': 'FG004', 'numSubjects': '77'}, {'groupId': 'FG005', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '87', 'groupId': 'BG005'}, {'value': '519', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG001', 'title': '20 mg LY3015014 Q4W', 'description': '20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG002', 'title': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG003', 'title': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG004', 'title': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG005', 'title': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '59.6', 'spread': '8.1', 'groupId': 'BG004'}, {'value': '58.7', 'spread': '10.1', 'groupId': 'BG005'}, {'value': '58.4', 'spread': '10.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '241', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '278', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '315', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '191', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '356', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '94', 'groupId': 'BG006'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '88', 'groupId': 'BG006'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '106', 'groupId': 'BG006'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Serum LDL Cholesterol Beta Quantification', 'classes': [{'categories': [{'measurements': [{'value': '136.5', 'spread': '39.6', 'groupId': 'BG000'}, {'value': '134.1', 'spread': '42.4', 'groupId': 'BG001'}, {'value': '134.0', 'spread': '40.7', 'groupId': 'BG002'}, {'value': '132.1', 'spread': '42.3', 'groupId': 'BG003'}, {'value': '135.2', 'spread': '41.2', 'groupId': 'BG004'}, {'value': '146.0', 'spread': '60.5', 'groupId': 'BG005'}, {'value': '136.3', 'spread': '45.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2014-09-29', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2013-06-27', 'dispFirstSubmitQcDate': '2014-09-29', 'resultsFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2013-06-27', 'dispFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-25', 'studyFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline, Week 16', 'description': 'Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.'}, {'measure': 'Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]', 'timeFrame': 'Baseline, Week 16', 'description': 'Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.'}, {'measure': 'Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.'}, {'measure': 'Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.'}, {'measure': 'Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels', 'timeFrame': 'Baseline, Week 16', 'description': 'LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014', 'timeFrame': 'Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose'}, {'measure': 'Number of Participants With an Injection Site Reaction', 'timeFrame': 'Baseline through Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with high low density lipoprotein (LDL) cholesterol\n* Are on stable daily dose of a statin or have a history of statin intolerance\n* Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies\n* Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies\n\nExclusion Criteria:\n\n* Have high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol\n* Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well\n* Have poorly controlled high blood pressure\n* Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled\n* Have thyroid blood test that is outside normal range\n* Have a history of adrenal gland disorder\n* Have a history of vitamin E deficiency or fat malabsorption syndrome\n* Have poor kidney function\n* Have active liver or gall bladder disease, history of hepatitis or liver blood tests that are high\n* Have a history of muscle disease including muscle damage from a medicine or muscle blood test that is high\n* Are anemic (low red blood cell counts)\n* Have a history of allergy or intolerance to other antibody medications\n* Have a history of human immunodeficiency virus infection (HIV) infection\n* Are likely to have a major operation or be hospitalized during the study\n* Have chronic alcohol or drug abuse or dependency\n* Have or suspected to have any cancer or malignant tumor\n* Have an active serious infection\n* Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen recently\n* Are on a statin regimen other than daily dosing (for example, an every-other-day statin regimen)\n* Have recently used simvastatin (highest dose level), fibrates, bile acid binders, niacin, probucol, or over-the-counter/health food preparations to lower cholesterol (such as red yeast rice, fish oil, omega 3 fatty acid)\n* Have undergone LDL apheresis in the past 1 year\n* Have recently used steroids, cyclosporine or isotretinoin\n* Have recently used an immunosuppressive therapy\n* Have recently received treatment with another antibody medication\n* Are currently using medications injected into the skin , except for single injections (for example flu vaccines) or injections into muscles\n* Are currently on a prescription or over-the-counter medicine for weight loss or are on a very low carbohydrate diet'}, 'identificationModule': {'nctId': 'NCT01890967', 'briefTitle': 'A Study of LY3015014 in Participants With High Cholesterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': '14853'}, 'secondaryIdInfos': [{'id': 'I5S-MC-EFJE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 mg LY3015014 Q4W', 'description': '20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: LY3015014', 'Drug: Statin', 'Drug: Ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': '120 mg LY3015014 Q4W', 'description': '120 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: LY3015014', 'Drug: Statin', 'Drug: Ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': '300 mg LY3015014 Q4W', 'description': '300 mg LY3015014 given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: LY3015014', 'Drug: Statin', 'Drug: Ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': '100 mg LY3015014 Q8W', 'description': '100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: LY3015014', 'Drug: Statin', 'Drug: Ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': '300 mg LY3015014 Q8W', 'description': '300 mg LY3015014 given SC Q8W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: LY3015014', 'Drug: Statin', 'Drug: Ezetimibe']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Q4W', 'description': 'Placebo given SC Q4W for 16 weeks.\n\nParticipants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.', 'interventionNames': ['Drug: Placebo', 'Drug: Statin', 'Drug: Ezetimibe']}], 'interventions': [{'name': 'LY3015014', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['100 mg LY3015014 Q8W', '120 mg LY3015014 Q4W', '20 mg LY3015014 Q4W', '300 mg LY3015014 Q4W', '300 mg LY3015014 Q8W']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo Q4W']}, {'name': 'Statin', 'type': 'DRUG', 'otherNames': ['atorvastatin', 'simvastatin', 'rosuvastatin', 'pravastatin', 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1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2100 CPH', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'For 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personal physician.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '4811 SW', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '4462 RA', 'city': 'Goes', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50417, 'lon': 3.88889}}, {'zip': '9711 SG', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6525 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3021 HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '15-351', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-546', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '30-015', 'city': 'Krakow', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-242', 'city': 'Lodz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-582', 'city': 'Lublin', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '00717-1322', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. 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