Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-01 @ 3:53 AM
Study NCT ID:
NCT03851705
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2019-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}], 'ancestors': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'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': 'D007267', 'term': 'Injections'}, {'id': 'C585830', 'term': 'ALN-PCS'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years.', 'description': 'Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) Inclisiran for injection administered by SC injection on Day 1 and Day 90.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 12, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1: Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 6, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1:All Patients', 'description': 'Total of all patients', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 18, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part 2: Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran for injection administered by SC injection on Day 270, Day 450 and Day 630.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 29, 'seriousNumAtRisk': 53, 'deathsNumAffected': 3, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Scleral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastrooesophageal sphincter insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Bacterial vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Genitourinary chlamydia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory 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'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 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In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. 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The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants will receive a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': 'Day 90', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '-40.3', 'upperLimit': '47.8'}, {'value': '-15.3', 'groupId': 'OG001', 'lowerLimit': '-46.5', 'upperLimit': '15.9'}]}]}, {'title': 'Day 150', 'categories': [{'measurements': [{'value': '-11.6', 'groupId': 'OG000', 'lowerLimit': '-66.4', 'upperLimit': '43.3'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-39.1', 'upperLimit': '40.3'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '-5.7', 'groupId': 'OG000', 'lowerLimit': '-50.2', 'upperLimit': '38.9'}, {'value': '-12.7', 'groupId': 'OG001', 'lowerLimit': '-46.4', 'upperLimit': '21.0'}]}]}], 'analyses': [{'pValue': '0.4848', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.1', 'ciLowerLimit': '-73.6', 'ciUpperLimit': '35.3', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 90', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '-56.0', 'ciUpperLimit': '80.3', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 150', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-63.6', 'ciUpperLimit': '49.5', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 180', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute change in non-HDL-C levels from Baseline to subsequent visits up to Day 180', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.7', 'spread': '157.98', 'groupId': 'OG000'}, {'value': '-17.1', 'spread': '86.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.2', 'spread': '127.12', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '114.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 450', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '109.91', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '112.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.3', 'spread': '120.58', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '128.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 630', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-43.8', 'spread': '70.56', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '112.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.0', 'spread': '116.12', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '114.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.9', 'spread': '91.89', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '127.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute Change in non-HDL Cholesterol (non-HDL-C) from Baseline to Subsequent Visits up to Day 720', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.\n\n.'}, {'type': 'SECONDARY', 'title': 'Individual Responsiveness of Subjects: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': '<25 mg/dL- Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '<100 mg/dL- Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '<25 mg/dL- Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '<100 mg/dL- Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 150, 180', 'description': 'Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of \\<25 mg/dL, \\<50 mg/dL, \\<70 mg/dL, and \\<100 mg/dL up to Day 180', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Individual Responsiveness of Subjects: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': '<25 mg/dL- Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '<100 mg/dL- Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '<25 mg/dL- Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '< 100 mg/dL- Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '<25 mg/dL- Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '<100 mg/dL- Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '<25 mg/dL- Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '<50 mg/dL- Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '<70 mg/dL- Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '<100 mg/dL- Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>= 100 mg/dL- Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 330, 510, 690 and 720', 'description': 'Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of \\<25 mg/dL, \\<50 mg/dL, \\<70 mg/dL, and \\<100 mg/dL up to Day 720', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Proportional Responsiveness: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': 'Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 150, 180', 'description': 'Number of participants in each group who attain global lipid targets for their indication', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Proportional Responsiveness of Subjects: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 330, 510, 690 and 720', 'description': 'Number of participants in each group who attain global lipid targets for their indication', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. 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In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.05', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 450', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '8.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '7.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 630', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '7.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '9.57', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '8.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in LDL-C levels from Baseline to Subsequent Visits up to Day 720', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. 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In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. 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The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': 'Day 90', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '7.6'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '4.9'}]}]}, {'title': 'Day 150', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-5.1', 'upperLimit': '11.1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-5.5', 'upperLimit': '6.3'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '8.3'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-6.1', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.7958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '6.5', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 90', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '7.4', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 150', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '5.8', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 180', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in Apolipoprotein A-1 (Apo-A1) from baseline to subsequent visits on Day 90, 150, and 180', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Percent Change Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. 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In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '10.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 450', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '10.76', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '12.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '17.00', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '13.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 630', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '9.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '12.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '11.71', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '9.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in Apolipoprotein A-1 (Apo-A1) from Baseline to Subsequent Visits up to Day 720', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': 'Day 90', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '14.7'}, {'value': '-4.6', 'groupId': 'OG001', 'lowerLimit': '-12.2', 'upperLimit': '2.9'}]}]}, {'title': 'Day 150', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '37.2'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-19.8', 'upperLimit': '12.2'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '16.4'}, {'value': '-4.8', 'groupId': 'OG001', 'lowerLimit': '-13.5', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.1716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.9', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '4.0', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 90', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1671', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.0', 'ciLowerLimit': '-46.2', 'ciUpperLimit': '8.2', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 150', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1808', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.7', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '4.7', 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05 (two-sided)', 'groupDescription': 'Day 180', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in Lp(a) from Baseline to Subsequent Visits up to Day 180', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. 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In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '36.71', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '30.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 450', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '47.48', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '41.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '50.25', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '53.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 630', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '31.18', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '50.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '26.52', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '26.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '48.12', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '30.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in Lp(a) from Baseline to Subsequent Visits up to Day 720', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 180: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': '243.94', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '170.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '230.8', 'spread': '640.11', 'groupId': 'OG000'}, {'value': '126.9', 'spread': '380.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.1', 'spread': '490.17', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '143.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percent change in hsCRP from Baseline to subsequent visits up to Day 180', 'unitOfMeasure': 'Percentage Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 1): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178.9', 'spread': '657.67', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '73.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '266.7', 'spread': '936.76', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '204.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '125.18', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '92.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '167.16', 'groupId': 'OG000'}, {'value': '38.60', 'spread': '112.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 330, 510 ,690, 720', 'description': 'Percentage change in hsCRP from baseline to subsequent visits up to Day 720', 'unitOfMeasure': 'Percentage Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. 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The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'OG001', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'classes': [{'title': 'Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 510', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'Day 690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '10.21', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '3.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '4.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 330, 510, 690, 720', 'description': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) from baseline to subsequent visits up to Day 720', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apo-B From Baseline to Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'OG001', 'title': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'groupId': 'OG000', 'lowerLimit': '-13.60', 'upperLimit': '20.71'}, {'value': '-0.75', 'groupId': 'OG001', 'lowerLimit': '-11.50', 'upperLimit': '9.99'}]}]}], 'analyses': [{'pValue': '0.6814', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.31', 'ciLowerLimit': '-24.88', 'ciUpperLimit': '16.27', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Percentage change in Apo-B from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-HDL-C From Baseline to Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - 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Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.'}, {'id': 'FG001', 'title': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.'}, {'id': 'FG002', 'title': 'Part 2 - Placebo-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}, {'id': 'FG003', 'title': 'Part 2 - Inclisiran-Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.'}], 'periods': [{'title': 'Part 1: Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 56 subjects were enrolled and 53 subjects completed through Day 180 (Part 1) and went into the Open-Label period (Part 2), in which 47 subjects completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inclisiran', 'description': 'Participants who received a dose of inclisiran sodium for injection administered by sub-cutaneous (SC) injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants who received a dose of placebo administered by sub-cutaneous (SC) injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-08', 'size': 677230, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 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'studyFirstSubmitDate': '2019-02-07', 'dispFirstSubmitQcDate': '2022-10-14', 'resultsFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2019-02-20', 'dispFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-14', 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Percentage Change in LDL-C levels from Baseline to Day 150'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Absolute Change in LDL-C levels (mg/dL) from baseline to Day 150'}, {'measure': 'Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in LDL-C levels from baseline to subsequent visits on Days 90, 150, and 180'}, {'measure': 'Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Percentage Change in LDL-C levels from baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute change in LDL-C levels (mg/dL) from baseline to subsequent visits on Days 90, 150 and 180 based on the'}, {'measure': 'Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in LDL-C levels from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Percent Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in PCSK9 from baseline to subsequent visits up to Day 180'}, {'measure': 'Percent Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Percentage Change in PCSK9 from baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in PCSK9 from baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute Change in PCSK9 from baseline to subsequent visits up to Day 720'}, {'measure': 'Percent Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150 and 180', 'description': 'Percentage change in total cholesterol from baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in total cholesterol from baseline to subsequent visits up to Day 180'}, {'measure': 'Percent Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in total cholesterol from baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute Change in total cholesterol from baseline to subsequent visits up to Day 720'}, {'measure': 'Percent Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 180 demonstrated by Mixed Model Repeated Measures statisitical method.'}, {'measure': 'Percent Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Percentage Change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in Apolipoprotein B (Apo B) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute Change in Apolipoprotein B (Apo B) from baseline to subsequent visits up to Day 720'}, {'measure': 'Percent Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage change in non-HDL-C levels from baseline to subsequent visits up to Day 180'}, {'measure': 'Percent Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Percentage Change in non-HDL-C from Baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute change in non-HDL-C levels from Baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 270, 330, 450, 510, 630, 690, and 720', 'description': 'Absolute Change in non-HDL Cholesterol (non-HDL-C) from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Individual Responsiveness of Subjects: Part 1', 'timeFrame': 'Days 150, 180', 'description': 'Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of \\<25 mg/dL, \\<50 mg/dL, \\<70 mg/dL, and \\<100 mg/dL up to Day 180'}, {'measure': 'Individual Responsiveness of Subjects: Part 2', 'timeFrame': 'Days 330, 510, 690 and 720', 'description': 'Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of \\<25 mg/dL, \\<50 mg/dL, \\<70 mg/dL, and \\<100 mg/dL up to Day 720'}, {'measure': 'Proportional Responsiveness: Part 1', 'timeFrame': 'Days 150, 180', 'description': 'Number of participants in each group who attain global lipid targets for their indication'}, {'measure': 'Proportional Responsiveness of Subjects: Part 2', 'timeFrame': 'Days 330, 510, 690 and 720', 'description': 'Number of participants in each group who attain global lipid targets for their indication'}, {'measure': 'LDL-C Reduction ≥20% or ≥30% From Baseline: Part 1', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Proportion of subjects in each group with ≥20% or ≥30% LDL-C reduction from Baseline in Part 1 (Days 90, 150, 180)'}, {'measure': 'LDL-C Reduction ≥20% or ≥30% From Baseline: Part 2', 'timeFrame': 'Baseline, Days 330, 510, 690, and 720', 'description': 'Proportion of subjects in each group with ≥20% or ≥30% LDL-C reduction from Baseline in Part 2 (Days 330, 510, 690, and 720)'}, {'measure': 'Percent Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in HDL-C levels (mg/dL) from baseline to subsequent visits on Day 90, 150, and 180'}, {'measure': 'Percent Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in LDL-C levels from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Absolute Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in HDL-C levels (mg/dL) from baseline to subsequent visits on Day 90, 150, and 180'}, {'measure': 'Absolute Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in LDL-C levels from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Absolute Change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in VLDL-C levels from baseline to subsequent visits on Days 90, 150, and 180'}, {'measure': 'Absolute Change in Very-Low-Density-Lipoprotein Cholesterol Levels (VLDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in VLDL-C levels from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Percent Change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in VLDL-C levels (mg/dL) from baseline to subsequent visits on Days 90, 150, and 180'}, {'measure': 'Percent Change in Very-Low-Density-Lipoprotein Cholesterol Levels (VLDL-C) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in VLDL-C levels from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Absolute Change in Apolipoprotein A-1 (Apo-A1) mg/dL From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in Apolipoprotein A-1 (Apo-A1) from baseline to subsequent visits on Days 90, 150, and 180'}, {'measure': 'Absolute Change Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in Apolipoprotein A-1 (Apo-A1) from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Percent Change in Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in Apolipoprotein A-1 (Apo-A1) from baseline to subsequent visits on Day 90, 150, and 180'}, {'measure': 'Percent Change Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in Apolipoprotein A-1 (Apo-A1) from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percentage Change in Lp(a) from Baseline to Subsequent Visits up to Day 180'}, {'measure': 'Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Percentage change in Lp(a) from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Absolute Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 180', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in Lp(a) from baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 720', 'timeFrame': 'Baseline, Days 330, 450, 510, 630, 690, and 720', 'description': 'Absolute change in Lp(a) from Baseline to Subsequent Visits up to Day 720'}, {'measure': 'Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 180: Part 1', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Percent change in hsCRP from Baseline to subsequent visits up to Day 180'}, {'measure': 'Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2', 'timeFrame': 'Baseline, Days 330, 510 ,690, 720', 'description': 'Percentage change in hsCRP from baseline to subsequent visits up to Day 720'}, {'measure': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 180: Part 1', 'timeFrame': 'Baseline, Days 90, 150, 180', 'description': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) from Baseline to subsequent visits up to Day 180'}, {'measure': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2', 'timeFrame': 'Baseline, Days 330, 510, 690, 720', 'description': 'Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) from baseline to subsequent visits up to Day 720'}, {'measure': 'Percent Change in Apo-B From Baseline to Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Percentage change in Apo-B from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.'}, {'measure': 'Percent Change in Non-HDL-C From Baseline to Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Percentage Change in non-HDL-C from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.'}, {'measure': 'Percent Change in Total Cholesterol From Baseline to Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Percentage change in total cholesterol from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.'}, {'measure': 'Proportion of Subjects With ≥30% LDL-C Reduction of From Baseline at Day 150', 'timeFrame': 'Baseline, Day 150', 'description': 'Number of participants in each group with ≥30% LDL-C reduction from baseline at Day 150 using the Regression Logistic Statistical Model'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HoFH'], 'conditions': ['Homozygous Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '37850379', 'type': 'DERIVED', 'citation': 'Raal F, Durst R, Bi R, Talloczy Z, Maheux P, Lesogor A, Kastelein JJP; ORION-5 Study Investigators. Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial. Circulation. 2024 Jan 30;149(5):354-362. doi: 10.1161/CIRCULATIONAHA.122.063460. Epub 2023 Oct 18.'}, {'pmid': '33990512', 'type': 'DERIVED', 'citation': 'Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1197', 'label': 'A Plain Language Trial Summary is available on novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).', 'detailedDescription': 'This study had two sequential parts:\n\n* Part 1: 6-month double-blind period in which subjects were randomized to receive either inclisiran or placebo\n* Part 2: 18-month open-label follow-up period; placebo-treated subjects from Part 1 were transitioned to inclisiran at Day 180 and all subjects who participated in an open-label follow-up period of inclisiran only'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of HoFH by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL-C concentration \\>500 mg/dL (13 mmol/L) together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents\n2. Stable on a low-fat diet.\n3. Subjects on statins should be receiving a maximally tolerated dose. Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable adverse events.\n4. Subjects not receiving statins must have documented evidence of intolerance to at least two different statins.\n5. Subjects on lipid-lower therapies (such as statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.\n6. Fasting central laboratory LDL-C concentration ≥130 mg/dL (3.4 mmol/L).\n7. Triglyceride concentration \\<400 mg/dL (4.5 mmol/L)\n8. No current or planned renal dialysis or renal transplantation\n9. Subjects on a documented regimen of LDL or plasma apheresis will be allowed to continue the apheresis during the study, if needed.\n10. Subjects must be willing and able to give written informed consent before initiation of any study-related procedures. The subject should be willing to comply with all required study procedures.\n11. Willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.\n\nExclusion Criteria:\n\n1. Use of Mipomersen or Lomitapide therapy within 5 months of screening\n2. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9\n3. New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \\<25%\n4. Major adverse cardiovascular event within 3 months prior to randomization\n5. Planned cardiac surgery or revascularization\n6. Uncontrolled severe hypertension: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg prior to randomization despite anti-hypertensive therapy\n7. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation \\>3x ULN, or total bilirubin \\>2x upper limit of normal (ULN) at screening confirmed by a repeat measurement at least 1 week apart\n8. Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than the duration of the trial\n9. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or commencement of systemic therapy as treatment during the 3 years prior to randomization\n10. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one acceptable effective method of contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:\n\n 1. Women \\>2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age\n 2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of enrolment\n 3. Women who are surgically sterilized at least 3 months prior to enrolment\n11. Known history of alcohol and/or drug abuse within 5 years\n12. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:\n\n 1. Subjects who are unable to communicate or to cooperate with the investigator.\n 2. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)\n 3. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)\n 4. Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study\n 5. Persons directly involved in the conduct of the study\n13. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator's \\[or delegate\\] judgment) if he/she participates in the clinical study\n14. Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator, might interfere with the interpretation of clinical study results\n15. Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer\n16. Previous participation in the study\n17. Hypersensitivity to any of the ingredients of Inclisiran\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03851705', 'acronym': 'ORION-5', 'briefTitle': 'A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (Hofh) (ORION-5)', 'orgStudyIdInfo': {'id': 'MDCO-PCS-17-02'}, 'secondaryIdInfos': [{'id': 'CKJX839A12302', 'type': 'OTHER', 'domain': 'Novartis Pharmaceuticals'}, {'id': '2018-000893-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Inclisiran', 'description': 'Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.', 'interventionNames': ['Drug: Inclisiran Sodium for injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 - Placebo', 'description': 'Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.', 'interventionNames': ['Drug: Placebo', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Inclisiran', 'description': 'Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 will receive a dose of 300 mg inclisiran sodium administered by SC injection on Day 180 after completion of Part 1.', 'interventionNames': ['Drug: Inclisiran Sodium for injection']}], 'interventions': [{'name': 'Inclisiran Sodium for injection', 'type': 'DRUG', 'otherNames': ['ALN-PCSSC; KJX839', 'ALN-PCSSC'], 'description': 'Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.', 'armGroupLabels': ['Part 1 - Inclisiran', 'Part 2 - Inclisiran']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile normal saline (0.9% sodium chloride in water for injection)', 'armGroupLabels': ['Part 1 - Placebo']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Sterile normal saline (0.9% sodium chloride in water for injection)', 'armGroupLabels': ['Part 1 - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': '(50852-001) Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': '(50972-001) Hadassah Hospital Lipid Research Ein Kerem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': '(50007-001) Research Institute of Complex Issues of Cardiovascular Diseases', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': '(50007-003) National Medical Research Centre of Cardiology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '193079', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': '(50007-002) Hospital for War Veterans', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': '(50381-001) Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '2193', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': '(50027-001) Johannesburg Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': '(50886-001) Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '06010', 'city': 'Etlik', 'country': 'Turkey (Türkiye)', 'facility': '(50090-002) University of Health Sciences', 'geoPoint': {'lat': 39.98205, 'lon': 32.82459}}, {'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': '(50090-003) Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35040', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': '(50090-001) Ege Universitesi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': '(50380-002) IMunicipal Non-commercial Enterprise "Ivano-Frankivsk Regional Clinical Cardiology Center Ivano-Frankivsk Regional Council"', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '03680', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': '(50380-001) National Scientific Center', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}