Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-03-09 @ 4:21 AM
Study NCT ID:
NCT03175367
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}}}}, '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': 'C000621590', 'term': 'evinacumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '8447346643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks', 'description': '1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant\'s safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 20, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 27, 'seriousNumAtRisk': 39, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 26, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 22, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Group B: Placebo IV Q4W (DBTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 18, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 23, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 24, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG007', 'title': 'Group B: Placebo IV Q4W (OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 19, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 22, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 24, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 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'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal 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{'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 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'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on 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assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '6.4', 'groupId': 'OG000', 'lowerLimit': '6.4'}, {'value': '-29.7', 'spread': '6.4', 'groupId': 'OG001', 'lowerLimit': '6.4'}, {'value': '-44.0', 'spread': '6.3', 'groupId': 'OG002', 'lowerLimit': '6.3'}, {'value': '-47.2', 'spread': '6.2', 'groupId': 'OG003', 'lowerLimit': '6.2'}, {'value': '0.6', 'spread': '6.6', 'groupId': 'OG004', 'lowerLimit': '6.6'}, {'value': '-23.5', 'spread': '6.6', 'groupId': 'OG005', 'lowerLimit': '6.6'}, {'value': '-49.9', 'spread': '6.1', 'groupId': 'OG006', 'lowerLimit': '6.1'}]}]}], 'analyses': [{'pValue': '< .0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.5', 'ciLowerLimit': '-56.5', 'ciUpperLimit': '-20.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.9', 'ciLowerLimit': '-70.7', 'ciUpperLimit': '-35.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.0', 'ciLowerLimit': '-73.7', 'ciUpperLimit': '-38.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.0', 'statisticalMethod': 'Mixed Models Analysis', 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'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 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IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '5.1', 'groupId': 'OG000', 'lowerLimit': '5.1'}, {'value': '-19.9', 'spread': '5.1', 'groupId': 'OG001', 'lowerLimit': '5.1'}, {'value': '-35.2', 'spread': '5.1', 'groupId': 'OG002', 'lowerLimit': '5.1'}, {'value': '-38.8', 'spread': '4.9', 'groupId': 'OG003', 'lowerLimit': '4.9'}, {'value': '-3.8', 'spread': '4.7', 'groupId': 'OG004', 'lowerLimit': '4.7'}, {'value': '-20.4', 'spread': '4.6', 'groupId': 'OG005', 'lowerLimit': '4.6'}, {'value': '-43.2', 'spread': '4.3', 'groupId': 'OG006', 'lowerLimit': '4.3'}]}]}], 'analyses': [{'pValue': '= 0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.6', 'ciLowerLimit': '-40.9', 'ciUpperLimit': '-12.4', 'dispersionType': 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'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-29.7', 'ciUpperLimit': '-3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.4', 'ciLowerLimit': '-52.0', 'ciUpperLimit': '-26.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '6.0', 'groupId': 'OG000', 'lowerLimit': '6.0'}, {'value': '-15.9', 'spread': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9'}, {'value': '-34.5', 'spread': '5.6', 'groupId': 'OG002', 'lowerLimit': '5.6'}]}]}], 'analyses': [{'pValue': '= 0.0111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.8', 'ciLowerLimit': '-38.4', 'ciUpperLimit': '-5.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.4', 'ciLowerLimit': '-56.7', 'ciUpperLimit': '-24.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '5.4', 'groupId': 'OG000', 'lowerLimit': '5.4'}, {'value': '-31.3', 'spread': '5.4', 'groupId': 'OG001', 'lowerLimit': '5.4'}, {'value': '-45.8', 'spread': '5.3', 'groupId': 'OG002', 'lowerLimit': '5.3'}, {'value': '-50.6', 'spread': '5.2', 'groupId': 'OG003', 'lowerLimit': '5.2'}, {'value': '-1.1', 'spread': '5.8', 'groupId': 'OG004', 'lowerLimit': '5.8'}, {'value': '-24.8', 'spread': '5.7', 'groupId': 'OG005', 'lowerLimit': '5.7'}, {'value': '-52.0', 'spread': '5.3', 'groupId': 'OG006', 'lowerLimit': '5.3'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.3', 'ciLowerLimit': '-54.4', 'ciUpperLimit': '-24.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.8', 'ciLowerLimit': '-68.8', 'ciUpperLimit': '-38.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.5', 'ciLowerLimit': '-73.4', 'ciUpperLimit': '-43.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0042', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.7', 'ciLowerLimit': '-39.7', 'ciUpperLimit': '-7.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.9', 'ciLowerLimit': '-66.4', 'ciUpperLimit': '-35.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '7.0', 'groupId': 'OG000', 'lowerLimit': '7.0'}, {'value': '-20.2', 'spread': '6.7', 'groupId': 'OG001', 'lowerLimit': '6.7'}, {'value': '-44.3', 'spread': '6.4', 'groupId': 'OG002', 'lowerLimit': '6.4'}]}]}], 'analyses': [{'pValue': '= 0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.6', 'ciLowerLimit': '-49.8', 'ciUpperLimit': '-11.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.6', 'ciLowerLimit': '-73.4', 'ciUpperLimit': '-35.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '68.1', 'groupId': 'OG001'}, {'value': '73.9', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}, {'value': '15.5', 'groupId': 'OG004'}, {'value': '57.9', 'groupId': 'OG005'}, {'value': '86.8', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '5.1', 'ciUpperLimit': '72.8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.9', 'ciLowerLimit': '6.4', 'ciUpperLimit': '89.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.1', 'ciLowerLimit': '6.0', 'ciUpperLimit': '80.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0007', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '2.5', 'ciUpperLimit': '29.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.3', 'ciLowerLimit': '10.4', 'ciUpperLimit': '172.3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '53.7', 'groupId': 'OG002'}, {'value': '60.6', 'groupId': 'OG003'}, {'value': '12.3', 'groupId': 'OG004'}, {'value': '24.6', 'groupId': 'OG005'}, {'value': '63.2', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '= 0.0100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '1.7', 'ciUpperLimit': '53.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.8', 'ciLowerLimit': '4.7', 'ciUpperLimit': '129.9', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.1', 'ciLowerLimit': '6.7', 'ciUpperLimit': '194.7', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.3185', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.5', 'ciUpperLimit': '8.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.5', 'ciLowerLimit': '3.9', 'ciUpperLimit': '54.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}, {'value': '40.8', 'groupId': 'OG003'}, {'value': '9.3', 'groupId': 'OG004'}, {'value': '13.2', 'groupId': 'OG005'}, {'value': '39.5', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '= 0.0718', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '0.9', 'ciUpperLimit': '26.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0048', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '2.1', 'ciUpperLimit': '62.1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.7', 'ciLowerLimit': '2.8', 'ciUpperLimit': '76.8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5270', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '8.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0047', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '1.9', 'ciUpperLimit': '31.7', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of Participants with Calculated LDL-C \\< 50 milligrams/deciliter (mg/dL) \\[1.30 Millimoles per liter (mmol/L)\\] at Week 16 (ITT Estimand)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '8.3', 'groupId': 'OG000', 'lowerLimit': '8.3'}, {'value': '-17.7', 'spread': '8.0', 'groupId': 'OG001', 'lowerLimit': '8.0'}, {'value': '-39.7', 'spread': '7.7', 'groupId': 'OG002', 'lowerLimit': '7.7'}]}]}], 'analyses': [{'pValue': '= 0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.5', 'ciLowerLimit': '-55.5', 'ciUpperLimit': '-9.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.5', 'ciLowerLimit': '-77.0', 'ciUpperLimit': '-32.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0'}, {'value': '-31.0', 'spread': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0'}, {'value': '-40.3', 'spread': '4.0', 'groupId': 'OG002', 'lowerLimit': '4.0'}, {'value': '-45.4', 'spread': '3.9', 'groupId': 'OG003', 'lowerLimit': '3.9'}, {'value': '-0.4', 'spread': '4.5', 'groupId': 'OG004', 'lowerLimit': '4.5'}, {'value': '-22.6', 'spread': '4.4', 'groupId': 'OG005', 'lowerLimit': '4.4'}, {'value': '-46.8', 'spread': '4.1', 'groupId': 'OG006', 'lowerLimit': '4.1'}]}]}], 'analyses': [{'pValue': '< .0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.1', 'ciLowerLimit': '-48.4', 'ciUpperLimit': '-25.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.4', 'ciLowerLimit': '-57.5', 'ciUpperLimit': '-35.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.5', 'ciLowerLimit': '-62.5', 'ciUpperLimit': '-40.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0006', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.2', 'ciLowerLimit': '-34.6', 'ciUpperLimit': '-9.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.4', 'ciLowerLimit': '-58.4', 'ciUpperLimit': '-34.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '5.1', 'groupId': 'OG000', 'lowerLimit': '5.1'}, {'value': '-19.9', 'spread': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.9'}, {'value': '-40.8', 'spread': '4.7', 'groupId': 'OG002', 'lowerLimit': '4.7'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.4', 'ciLowerLimit': '-42.6', 'ciUpperLimit': '-14.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.3', 'ciLowerLimit': '-63.2', 'ciUpperLimit': '-35.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.5'}, {'value': '-38.0', 'spread': '4.2', 'groupId': 'OG001', 'lowerLimit': '4.2'}, {'value': '-47.7', 'spread': '4.0', 'groupId': 'OG002', 'lowerLimit': '4.0'}, {'value': '-53.4', 'spread': '3.9', 'groupId': 'OG003', 'lowerLimit': '3.9'}, {'value': '-6.9', 'spread': '4.7', 'groupId': 'OG004', 'lowerLimit': '4.7'}, {'value': '-32.1', 'spread': '4.5', 'groupId': 'OG005', 'lowerLimit': '4.5'}, {'value': '-52.8', 'spread': '4.1', 'groupId': 'OG006', 'lowerLimit': '4.1'}]}]}], 'analyses': [{'pValue': '< .0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.1', 'ciLowerLimit': '-57.8', 'ciUpperLimit': '-34.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.0', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.8', 'ciLowerLimit': '-67.3', 'ciUpperLimit': '-44.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.9', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.5', 'ciLowerLimit': '-72.9', 'ciUpperLimit': '-50.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.8', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.2', 'ciLowerLimit': '-38.0', 'ciUpperLimit': '-12.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.9', 'ciLowerLimit': '-58.4', 'ciUpperLimit': '-33.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '5.4', 'groupId': 'OG000', 'lowerLimit': '5.4'}, {'value': '-23.2', 'spread': '5.1', 'groupId': 'OG001', 'lowerLimit': '5.1'}, {'value': '-51.3', 'spread': '4.8', 'groupId': 'OG002', 'lowerLimit': '4.8'}]}]}], 'analyses': [{'pValue': '= 0.0228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.1', 'ciLowerLimit': '-31.8', 'ciUpperLimit': '-2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< .0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.3', 'ciLowerLimit': '-59.6', 'ciUpperLimit': '-31.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'OG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'OG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.9'}, {'value': '-10.3', 'spread': '4.1', 'groupId': 'OG001', 'lowerLimit': '4.1'}, {'value': '-11.6', 'spread': '4.0', 'groupId': 'OG002', 'lowerLimit': '4.0'}, {'value': '-8.9', 'spread': '4.0', 'groupId': 'OG003', 'lowerLimit': '4.0'}, {'value': '0.8', 'spread': '3.7', 'groupId': 'OG004', 'lowerLimit': '3.7'}, {'value': '-15.7', 'spread': '3.7', 'groupId': 'OG005', 'lowerLimit': '3.7'}, {'value': '-15.7', 'spread': '3.3', 'groupId': 'OG006', 'lowerLimit': '3.3'}]}]}], 'analyses': [{'pValue': '= 0.0635', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.7', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0314', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.9', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '-1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0923', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0017', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.5', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '-6.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0009', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.5', 'ciLowerLimit': '-26.2', 'ciUpperLimit': '-6.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'OG001', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'OG002', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.1', 'groupId': 'OG000', 'lowerLimit': '4.1'}, {'value': '-17.5', 'spread': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0'}, {'value': '-16.0', 'spread': '3.7', 'groupId': 'OG002', 'lowerLimit': '3.7'}]}]}], 'analyses': [{'pValue': '= 0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '-4.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.8', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0085', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-25.4', 'ciUpperLimit': '-3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'FG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'FG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'FG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'FG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'FG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'FG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}], 'periods': [{'title': 'Double-blind Treatment Period (DBTP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '35'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Treatment Period (OLTP)', 'milestones': [{'type': 'STARTED', 'comment': 'Treated in OLTP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'comment': 'One participant completed DBTP, but did not continue to OLTP', 'groupId': 'FG006', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 327 participants were screened and 272 participants randomized. Six participants were randomized but never treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '266', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: Placebo SC QW (DBTP)', 'description': 'Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period'}, {'id': 'BG001', 'title': 'Group A: Evinacumab 300 mg SC Q2W (DBTP)', 'description': 'Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'BG002', 'title': 'Group A: Evinacumab 300 mg SC QW (DBTP)', 'description': 'Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'BG003', 'title': 'Group A: Evinacumab 450 mg SC QW (DBTP)', 'description': 'Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period'}, {'id': 'BG004', 'title': 'Group B: Placebo IV Q4W (DBTP to OLTP)', 'description': 'Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP'}, {'id': 'BG005', 'title': 'Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'BG006', 'title': 'Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)', 'description': 'Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '214', 'groupId': 'BG007'}]}]}, {'title': 'From 65-84 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}]}]}, {'title': '85 years and over', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '159', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '107', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}, {'value': '237', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}], '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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}, {'value': '239', 'groupId': 'BG007'}]}, {'title': 'More than one race', '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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-11', 'size': 962295, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-19T09:40', 'hasProtocol': True}, {'date': '2019-10-18', 'size': 922327, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-19T09:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'dispFirstSubmitDate': '2021-05-20', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2017-06-01', 'dispFirstSubmitQcDate': '2023-01-27', 'resultsFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2017-06-01', 'dispFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-27', 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)', 'timeFrame': 'Baseline and Week 16'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)', 'timeFrame': 'Week 16'}, {'measure': 'Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)', 'timeFrame': 'Week 16'}, {'measure': 'Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)', 'timeFrame': 'Week 16', 'description': 'Percentage of Participants with Calculated LDL-C \\< 50 milligrams/deciliter (mg/dL) \\[1.30 Millimoles per liter (mmol/L)\\] at Week 16 (ITT Estimand)'}, {'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)', 'timeFrame': 'Baseline and Week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '37703006', 'type': 'DERIVED', 'citation': 'Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, McGinniss J, Gaudet D, Pordy R. Longer-Term Efficacy and Safety of Evinacumab in Patients With Refractory Hypercholesterolemia. JAMA Cardiol. 2023 Nov 1;8(11):1070-1076. doi: 10.1001/jamacardio.2023.2921.'}, {'pmid': '33196153', 'type': 'DERIVED', 'citation': 'Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion/ exclusion criteria below, include, but are not limited to, the following:\n\nKey Inclusion Criteria:\n\n1. Men and women, ages 18 through 80 at the screening visit\n2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD\n3. A history of clinical ASCVD, for those patients who are non-HeFH.\n4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening\n5. For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins.\n6. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit\n7. For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed)\n8. For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)\n9. Provide signed informed consent\n\nKey Exclusion Criteria:\n\n1. Known history of homozygous FH (clinically, or by previous genotyping)\n2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins\n3. Newly diagnosed diabetes (within 3 months prior to screening)\n4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)\n5. Laboratory findings during screening period (not including randomization labs):\n\n 1. Triglycerides \\> 400 mg/dL (\\> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides \\> 300 mg/dL (\\> 3.39 mmol/L) for patients with a known history of diabetes mellitus\n 2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid \\[RNA\\] polymerase chain reaction)\n 3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential\n 4. Estimated glomerular filtration rate \\< 30 mL/min/1.73 m\\^2\n 5. TSH \\> 1.5 x ULN\n 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 x ULN\n6. Systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg at screening visit or time of randomization\n7. History of heart failure (New York Heart Association \\[NYHA\\] Class III-IV) within 12 months before screening\n8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening\n9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)\n10. Having received LDL apheresis within 2 months before screening\n11. Pregnant or breast-feeding women\n12. Women of childbearing potential who are unwilling to practice a highly effective birth control method\n13. Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status.'}, 'identificationModule': {'nctId': 'NCT03175367', 'briefTitle': 'Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy', 'orgStudyIdInfo': {'id': 'R1500-CL-1643'}, 'secondaryIdInfos': [{'id': '2017-001508-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: dosing regimen 1', 'description': 'SC Evinacumab QW for 16 weeks', 'interventionNames': ['Drug: Evinacumab', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A: dosing regimen 2', 'description': 'SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)', 'interventionNames': ['Drug: Evinacumab', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A: dosing regimen 3', 'description': 'SC Evinacumab QW for 16 weeks', 'interventionNames': ['Drug: Evinacumab', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group A: matching placebo', 'description': 'Placebo SC QW for 16 weeks', 'interventionNames': ['Drug: Matching placebo', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: dosing regimen 1', 'description': 'Intravenous (IV) Evinacumab Q4W for 24 weeks', 'interventionNames': ['Drug: Evinacumab', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: dosing regimen 2', 'description': 'IV Evinacumab Q4W for 24 weeks', 'interventionNames': ['Drug: Evinacumab', 'Other: Background Lipid Modifying Therapy (LMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: matching placebo', 'description': 'Placebo IV Q4W for 24 weeks', 'interventionNames': ['Drug: Matching placebo', 'Other: Background Lipid Modifying Therapy (LMT)']}], 'interventions': [{'name': 'Evinacumab', 'type': 'DRUG', 'otherNames': ['REGN1500'], 'description': 'SC or IV administration', 'armGroupLabels': ['Group A: dosing regimen 1', 'Group A: dosing regimen 2', 'Group A: dosing regimen 3', 'Group B: dosing regimen 1', 'Group B: dosing regimen 2']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'SC or IV administration', 'armGroupLabels': ['Group A: matching placebo', 'Group B: matching placebo']}, {'name': 'Background Lipid Modifying Therapy (LMT)', 'type': 'OTHER', 'description': 'All participants should be on a stable, maximally tolerated statin throughout the duration of the study. 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