Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-01 @ 5:22 AM
Study NCT ID:
NCT04270760
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723009', 'term': 'olpasiran'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.', 'description': 'FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1; Treatment Period: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 35, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2; Treatment Period: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 40, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group 3; Treatment Period: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 37, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Group 4; Treatment Period: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 36, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Group 5; Treatment Period: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 29, 'seriousNumAtRisk': 54, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W', 'description': 'After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 18, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W', 'description': 'After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 25, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W', 'description': 'After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 21, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG008', 'title': 'Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W', 'description': 'After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 17, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'Group 5; Extended Safety Follow-up: Placebo Q12W', 'description': 'After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 17, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG009', 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'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': 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54, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 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{'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.91', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-93.78', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '-97.53', 'spread': '1.82', 'groupId': 'OG002'}, {'value': '-96.89', 'spread': '1.85', 'groupId': 'OG003'}, {'value': '3.60', 'spread': '1.89', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.51', 'ciLowerLimit': '-75.12', 'ciUpperLimit': '-65.90', 'pValueComment': 'Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Group 1 versus (vs) Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-97.38', 'ciLowerLimit': '-101.98', 'ciUpperLimit': '-92.77', 'pValueComment': 'Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-101.13', 'ciLowerLimit': '-105.79', 'ciUpperLimit': '-96.47', 'pValueComment': 'Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100.49', 'ciLowerLimit': '-105.16', 'ciUpperLimit': '-95.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 36', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.', 'unitOfMeasure': 'Percentage Change in Lp(a)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Lp(a) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-64.89', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-92.54', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '-97.29', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '-82.36', 'spread': '2.25', 'groupId': 'OG003'}, {'value': '3.59', 'spread': '2.30', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-68.47', 'ciLowerLimit': '-74.27', 'ciUpperLimit': '-62.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.96', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Group 1 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-96.12', 'ciLowerLimit': '-101.92', 'ciUpperLimit': '-90.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.96', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100.88', 'ciLowerLimit': '-106.74', 'ciUpperLimit': '-95.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-85.94', 'ciLowerLimit': '-91.83', 'ciUpperLimit': '-80.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.00', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.', 'unitOfMeasure': 'Percentage Change in Lp(a)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'classes': [{'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-17.425', 'spread': '4.258', 'groupId': 'OG000'}, {'value': '-16.284', 'spread': '4.259', 'groupId': 'OG001'}, {'value': '-16.733', 'spread': '4.389', 'groupId': 'OG002'}, {'value': '-18.462', 'spread': '4.428', 'groupId': 'OG003'}, {'value': '6.234', 'spread': '4.520', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-14.743', 'spread': '4.419', 'groupId': 'OG000'}, {'value': '-11.481', 'spread': '4.418', 'groupId': 'OG001'}, {'value': '-17.308', 'spread': '4.532', 'groupId': 'OG002'}, {'value': '-16.908', 'spread': '4.608', 'groupId': 'OG003'}, {'value': '10.113', 'spread': '4.688', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.659', 'ciLowerLimit': '-35.176', 'ciUpperLimit': '-12.143', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.874', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 1 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.518', 'ciLowerLimit': '-34.036', 'ciUpperLimit': '-11.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.875', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.967', 'ciLowerLimit': '-34.656', 'ciUpperLimit': '-11.278', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.962', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.696', 'ciLowerLimit': '-36.399', 'ciUpperLimit': '-12.993', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.969', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.856', 'ciLowerLimit': '-36.853', 'ciUpperLimit': '-12.859', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.119', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 1 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.594', 'ciLowerLimit': '-33.590', 'ciUpperLimit': '-9.598', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.118', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.421', 'ciLowerLimit': '-39.565', 'ciUpperLimit': '-15.277', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.194', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.021', 'ciLowerLimit': '-39.240', 'ciUpperLimit': '-14.801', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.232', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 36 and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.', 'unitOfMeasure': 'Percentage Change in LDL-C', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'classes': [{'title': 'Week 36', 'categories': [{'measurements': [{'value': '-11.496', 'spread': '2.886', 'groupId': 'OG000'}, {'value': '-9.302', 'spread': '2.885', 'groupId': 'OG001'}, {'value': '-10.241', 'spread': '2.960', 'groupId': 'OG002'}, {'value': '-11.378', 'spread': '3.012', 'groupId': 'OG003'}, {'value': '7.394', 'spread': '3.066', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-7.748', 'spread': '3.307', 'groupId': 'OG000'}, {'value': '-4.768', 'spread': '3.305', 'groupId': 'OG001'}, {'value': '-7.218', 'spread': '3.393', 'groupId': 'OG002'}, {'value': '-9.548', 'spread': '3.443', 'groupId': 'OG003'}, {'value': '12.292', 'spread': '3.501', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.890', 'ciLowerLimit': '-26.303', 'ciUpperLimit': '-11.477', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.779', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 1 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.696', 'ciLowerLimit': '-24.107', 'ciUpperLimit': '-9.284', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.778', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.635', 'ciLowerLimit': '-25.139', 'ciUpperLimit': '-10.131', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.825', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.772', 'ciLowerLimit': '-26.303', 'ciUpperLimit': '-11.241', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.839', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.', 'groupDescription': 'Week 36: Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.040', 'ciLowerLimit': '-28.757', 'ciUpperLimit': '-11.323', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.443', 'estimateComment': 'Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 1 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.060', 'ciLowerLimit': '-25.774', 'ciUpperLimit': '-8.345', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.442', 'estimateComment': 'Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 2 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.509', 'ciLowerLimit': '-28.336', 'ciUpperLimit': '-10.682', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.500', 'estimateComment': 'Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 3 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.839', 'ciLowerLimit': '-30.700', 'ciUpperLimit': '-12.979', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.517', 'estimateComment': 'Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.', 'groupDescription': 'Week 48: Group 4 vs Group 5', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 36 and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.', 'unitOfMeasure': 'Percentage Change in ApoB', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.'}, {'type': 'SECONDARY', 'title': 'Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'OG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 1 Hour Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '47.4', 'groupId': 'OG001'}, {'value': '220', 'spread': '218', 'groupId': 'OG002'}, {'value': '275', 'spread': '450', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 3 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '43.2', 'groupId': 'OG001'}, {'value': '291', 'spread': '273', 'groupId': 'OG002'}, {'value': '324', 'spread': '383', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 6-12 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '36', 'groupId': 'OG001'}, {'value': '420', 'spread': '432', 'groupId': 'OG002'}, {'value': '329', 'spread': '191', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 24-72 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.995', 'spread': '0.946', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '63.2', 'spread': '59.7', 'groupId': 'OG002'}, {'value': '103', 'spread': '47.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0315', 'spread': '0.134', 'groupId': 'OG001'}, {'value': '0.498', 'spread': '1.88', 'groupId': 'OG002'}, {'value': '0.0645', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: 1 Hour Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '73.6', 'spread': '43.6', 'groupId': 'OG001'}, {'value': '204', 'spread': '144', 'groupId': 'OG002'}, {'value': '253', 'spread': '247', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: 3 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '96.3', 'spread': '63.5', 'groupId': 'OG001'}, {'value': '278', 'spread': '193', 'groupId': 'OG002'}, {'value': '332', 'spread': '255', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: 6-12 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '54.7', 'groupId': 'OG001'}, {'value': '271', 'spread': '229', 'groupId': 'OG002'}, {'value': '315', 'spread': '191', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: 24-72 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.27', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '99', 'spread': '59.1', 'groupId': 'OG002'}, {'value': '96.3', 'spread': '50.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0599', 'spread': '0.168', 'groupId': 'OG001'}, {'value': '0.533', 'spread': '0.592', 'groupId': 'OG002'}, {'value': '0.127', 'spread': '0.693', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48', 'description': 'Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.\n\nLower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'FG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'FG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'FG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'FG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '54'}]}, {'type': 'Entered Extended Safety Follow-up Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 34 centers in Australia, Denmark, Iceland, the Netherlands, Canada, the United States, and Japan between 28 July 2020 and 08 November 2022.', 'preAssignmentDetails': 'The Treatment Period was 48 weeks with investigational product (IP) administered subcutaneously (SC) every 12 weeks (Q12W) or 24 weeks (Q24W). After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks. Participants remained on standard of care per their local guidelines during the Treatment Period and Extended Safety Follow-up Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '281', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Olpasiran 10 mg Q12W', 'description': 'Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'BG001', 'title': 'Group 2: Olpasiran 75 mg Q12W', 'description': 'Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'BG002', 'title': 'Group 3: Olpasiran 225 mg Q12W', 'description': 'Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'BG003', 'title': 'Group 4: Olpasiran 225 mg Q24W', 'description': 'Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'BG004', 'title': 'Group 5: Placebo Q12W', 'description': 'Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '61.8', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '63.4', 'spread': '8.9', 'groupId': 'BG004'}, {'value': '61.9', 'spread': '9.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 - 64 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '29', 'groupId': 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'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '191', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '275', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 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'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '248', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): includes all randomized participants who received at least one dose of IP.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-02', 'size': 1323517, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-01T17:40', 'hasProtocol': True}, {'date': '2022-05-10', 'size': 389473, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-01T17:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2022-10-20', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2020-02-13', 'dispFirstSubmitQcDate': '2022-10-20', 'resultsFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2020-02-13', 'dispFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36', 'timeFrame': 'Baseline and Week 36', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in Lp(a) at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.'}, {'measure': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48', 'timeFrame': 'Baseline; Week 36 and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48', 'timeFrame': 'Baseline; Week 36 and Week 48', 'description': 'Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.'}, {'measure': 'Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48', 'timeFrame': 'Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48', 'description': 'Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.\n\nLower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Olpasiran', 'AMG 890', 'siRNA', 'lipoprotein (a) Lp(a)', 'Cardiovascular', 'Cardiovascular disease', 'Atherosclerotic cardiovascular disease', 'Cholesterol', 'Apolipoprotein (B)', 'Hyperlipidemia', 'Dyslipidemia'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '35588897', 'type': 'BACKGROUND', 'citation': "O'Donoghue ML, G Lopez JA, Knusel B, Gencer B, Wang H, Wu Y, Kassahun H, Sabatine MS. Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE). Am Heart J. 2022 Sep;251:61-69. doi: 10.1016/j.ahj.2022.05.004. Epub 2022 May 16."}, {'pmid': '36342163', 'type': 'BACKGROUND', 'citation': "O'Donoghue ML, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Ran X, Murphy SA, Wang H, Wu Y, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864. doi: 10.1056/NEJMoa2211023. Epub 2022 Nov 6."}, {'pmid': '39168564', 'type': 'BACKGROUND', 'citation': "O'Donoghue ML, Rosenson RS, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Murphy SA, Wang H, Wu Y, Shah T, Wang J, Wilmanski T, Sohn W, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. The Off-Treatment Effects of Olpasiran on Lipoprotein(a) Lowering: OCEAN(a)-DOSE Extension Period Results. J Am Coll Cardiol. 2024 Aug 27;84(9):790-797. doi: 10.1016/j.jacc.2024.05.058."}, {'pmid': '39565305', 'type': 'BACKGROUND', 'citation': "Kaur G, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Park JG, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML. Olpasiran lowering of lipoprotein(a) according to baseline levels: insights from the OCEAN(a)-DOSE study. Eur Heart J. 2025 Mar 24;46(12):1162-1164. doi: 10.1093/eurheartj/ehae781. No abstract available."}, {'pmid': '39937508', 'type': 'BACKGROUND', 'citation': "Rosenson RS, Lopez JAG, Gaudet D, Baum SJ, Stout E, Lepor NE, Park JG, Murphy SA, Knusel B, Wang J, Wilmanski T, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML; OCEAN(a)-DOSE Trial Investigators. Olpasiran, Oxidized Phospholipids, and Systemic Inflammatory Biomarkers: Results From the OCEAN(a)-DOSE Trial. JAMA Cardiol. 2025 May 1;10(5):482-486. doi: 10.1001/jamacardio.2024.5433."}, {'pmid': '38415744', 'type': 'DERIVED', 'citation': 'Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp\\[a\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 80 years\n* Lipoprotein (a) \\> 150 nmol/L\n* Evidence of atherosclerotic cardiovascular disease\n\nExclusion Criteria:\n\n* Severe renal dysfunction\n* History or clinical evidence of hepatic dysfunction\n* Malignancy within the last 5 years\n* Currently receiving, or less than 3 months at Day 1 since receiving \\> 200 mg/day Niacin'}, 'identificationModule': {'nctId': 'NCT04270760', 'briefTitle': 'Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) 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'facility': 'Research Institute of McGill University Health Center - Glen Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique des Maladies Lipidiques de Quebec Incorporated', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Regionshospitalet Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '201', 'city': 'Kopavogur', 'country': 'Iceland', 'facility': 'Thjonustumidstod Rannsoknaverkefna', 'geoPoint': {'lat': 64.11234, 'lon': -21.91298}}, {'zip': '289-2511', 'city': 'Asahi-shi', 'state': 'Chiba', 'country': 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There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}