Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:46 PM
Study NCT ID:
NCT05888103
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C585830', 'term': 'ALN-PCS'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 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': 'AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days', 'eventGroups': [{'id': 'EG000', 'title': 'Inclisiran - Inclisiran: Core Part', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): core part', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 40, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo - Inclisiran: Core Part', 'description': 'Placebo - inclisiran: core part', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 27, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Inclisiran - Inclisiran: Extension Part', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): extension part', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 25, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo - Inclisiran: Extension Part', 'description': 'Placebo - inclisiran: extension part', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 20, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.87', 'groupId': 'OG000', 'lowerLimit': '-49.33', 'upperLimit': '-42.42'}, {'value': '1.62', 'groupId': 'OG001', 'lowerLimit': '-1.77', 'upperLimit': '5.02'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.50', 'ciLowerLimit': '-52.35', 'ciUpperLimit': '-42.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.", 'unitOfMeasure': '% change in LDL-C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-69.05', 'groupId': 'OG000', 'lowerLimit': '-73.95', 'upperLimit': '-64.15'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '5.49'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-69.73', 'ciLowerLimit': '-76.60', 'ciUpperLimit': '-62.86', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.", 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-71.95', 'groupId': 'OG000', 'lowerLimit': '-77.68', 'upperLimit': '-66.22'}, {'value': '5.88', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '11.52'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-77.83', 'ciLowerLimit': '-85.86', 'ciUpperLimit': '-69.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. The percentage change from baseline in PCSK9 at Day 150 was assessed.', 'unitOfMeasure': '% change in PCSK9', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-217.14', 'groupId': 'OG000', 'lowerLimit': '-230.15', 'upperLimit': '-204.13'}, {'value': '9.47', 'groupId': 'OG001', 'lowerLimit': '-3.24', 'upperLimit': '22.17'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-226.61', 'ciLowerLimit': '-244.77', 'ciUpperLimit': '-208.45', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.88', 'groupId': 'OG000', 'lowerLimit': '-32.32', 'upperLimit': '-27.43'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '-0.78', 'upperLimit': '4.01'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.49', 'ciLowerLimit': '-34.91', 'ciUpperLimit': '-28.07', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.', 'unitOfMeasure': '% change in total cholesterol', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-68.82', 'groupId': 'OG000', 'lowerLimit': '-74.37', 'upperLimit': '-63.28'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '-2.80', 'upperLimit': '8.09'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.46', 'ciLowerLimit': '-79.24', 'ciUpperLimit': '-63.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '12.24', 'groupId': 'OG000', 'lowerLimit': '7.62', 'upperLimit': '16.86'}, {'value': '9.30', 'groupId': 'OG001', 'lowerLimit': '4.74', 'upperLimit': '13.86'}]}]}], 'analyses': [{'pValue': '0.3743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.94', 'ciLowerLimit': '-3.55', 'ciUpperLimit': '9.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.', 'unitOfMeasure': '% change in HDL-C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '4.66', 'groupId': 'OG000', 'lowerLimit': '2.80', 'upperLimit': '6.52'}, {'value': '3.60', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '5.43'}]}]}], 'analyses': [{'pValue': '0.4228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '3.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.71', 'groupId': 'OG000', 'lowerLimit': '-43.57', 'upperLimit': '-37.85'}, {'value': '-0.14', 'groupId': 'OG001', 'lowerLimit': '-2.93', 'upperLimit': '2.66'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.57', 'ciLowerLimit': '-44.57', 'ciUpperLimit': '-36.57', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.', 'unitOfMeasure': '% change in non-HDL-C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.48', 'groupId': 'OG000', 'lowerLimit': '-78.63', 'upperLimit': '-68.33'}, {'value': '-1.14', 'groupId': 'OG001', 'lowerLimit': '-6.19', 'upperLimit': '3.91'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-72.34', 'ciLowerLimit': '-79.56', 'ciUpperLimit': '-65.13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.63', 'groupId': 'OG000', 'lowerLimit': '-39.40', 'upperLimit': '-33.86'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '-2.50', 'upperLimit': '2.93'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.84', 'ciLowerLimit': '-40.72', 'ciUpperLimit': '-32.96', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.', 'unitOfMeasure': '% change in apolipoprotein B', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.64', 'groupId': 'OG000', 'lowerLimit': '-45.78', 'upperLimit': '-39.49'}, {'value': '-0.76', 'groupId': 'OG001', 'lowerLimit': '-3.85', 'upperLimit': '2.32'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.87', 'ciLowerLimit': '-46.28', 'ciUpperLimit': '-37.47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '7.88'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '5.79'}]}]}], 'analyses': [{'pValue': '0.3011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '5.93', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).', 'unitOfMeasure': '% change in apolipoprotein A-1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '10.16'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '-0.35', 'upperLimit': '6.98'}]}]}], 'analyses': [{'pValue': '0.2403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '-2.09', 'ciUpperLimit': '8.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.84', 'groupId': 'OG000', 'lowerLimit': '-31.20', 'upperLimit': '-16.48'}, {'value': '6.43', 'groupId': 'OG001', 'lowerLimit': '-0.77', 'upperLimit': '13.62'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.27', 'ciLowerLimit': '-40.58', 'ciUpperLimit': '-19.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.', 'unitOfMeasure': '% change in lipoprotein (a)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.74'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '1.09'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '3.49', 'groupId': 'OG000', 'lowerLimit': '-4.44', 'upperLimit': '11.43'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '-7.01', 'upperLimit': '7.97'}]}]}], 'analyses': [{'pValue': '0.5877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.01', 'ciLowerLimit': '-7.88', 'ciUpperLimit': '13.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.', 'unitOfMeasure': '% change in Triglyceride', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.32', 'groupId': 'OG000', 'lowerLimit': '-31.86', 'upperLimit': '1.22'}, {'value': '-7.36', 'groupId': 'OG001', 'lowerLimit': '-23.67', 'upperLimit': '8.94'}]}]}], 'analyses': [{'pValue': '0.5019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.96', 'ciLowerLimit': '-31.17', 'ciUpperLimit': '15.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 150', 'description': 'Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.45', 'groupId': 'OG000', 'lowerLimit': '-48.57', 'upperLimit': '-42.34'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 330', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.", 'unitOfMeasure': '% change in LDL-C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants in the Inclisiran - Inclisiran group'}, {'type': 'SECONDARY', 'title': 'Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-67.55', 'groupId': 'OG000', 'lowerLimit': '-72.39', 'upperLimit': '-62.72'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 330', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.", 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all treated participants in the Inclisiran - Inclisiran group'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) During Core Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'title': 'Adverse events (AEs)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': '-Adverse events Treatment-related', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (SAEs)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '-SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Fatal SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs requiring additional therapy', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Core part, from treatment start (Day 1) to Day 150', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set - all treated participants in the core part'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) During Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'title': 'Adverse events (AEs)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': '-Adverse events Treatment-related', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (SAEs)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Fatal SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs requiring additional therapy', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension part, from Day 181, up to Day 360', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analysis - all treated participants in the extension part'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'OG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': '-Adverse events Treatment-related', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '-SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Fatal SAEs Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-Treatment-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs requiring additional therapy', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analysis - all treated participants (Core + Extension part)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'FG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Completed Extension Part Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'comment': 'Completed core part study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Participant decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180'}, {'id': 'BG001', 'title': 'Placebo- Inclisiran', 'description': 'Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '9.97', 'groupId': 'BG000'}, {'value': '47.7', 'spread': '10.63', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '10.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', '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': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '207', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2023-02-24', 'size': 963912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-01T11:11', 'hasProtocol': True}, {'date': '2024-10-29', 'size': 731857, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-01T11:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor Personnel participating in the study conduct were also blinded during the during core part of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-center, randomized, double-blind, placebo-controlled, parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2023-05-24', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-01', 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body."}], 'secondaryOutcomes': [{'measure': 'Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body."}, {'measure': 'Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. The percentage change from baseline in PCSK9 at Day 150 was assessed.'}, {'measure': 'Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein.'}, {'measure': 'Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.'}, {'measure': 'Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.'}, {'measure': 'Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.'}, {'measure': 'Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.'}, {'measure': 'Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.'}, {'measure': 'Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.'}, {'measure': 'Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.'}, {'measure': 'Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.'}, {'measure': 'Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).'}, {'measure': 'Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).'}, {'measure': 'Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.'}, {'measure': 'Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.'}, {'measure': 'Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.'}, {'measure': 'Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part', 'timeFrame': 'Baseline, Day 150', 'description': 'Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.'}, {'measure': 'Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part', 'timeFrame': 'Baseline, Day 330', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body."}, {'measure': 'Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part', 'timeFrame': 'Baseline, Day 330', 'description': "Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body."}, {'measure': 'Number of Participants With Adverse Events (AEs) During Core Part', 'timeFrame': 'Core part, from treatment start (Day 1) to Day 150', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject'}, {'measure': 'Number of Participants With Adverse Events (AEs) During Extension Part', 'timeFrame': 'Extension part, from Day 181, up to Day 360', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject'}, {'measure': 'Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)', 'timeFrame': 'AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inclisiran', 'LDL-C', 'monotherapy', 'atherosclerotic cardiovascular disease', 'atheroma', 'Atherosclerosis', 'lipid', 'lipid lowering therapy (LLT)', 'cholesterol', 'hypercholesteremia', 'mixed dyslipidemia', 'TC (total cholesterol)', 'Apo B', 'non HDL-C', 'Lp(a)', 'PCSK9', 'PCSK9 inhibitor', 'siRNA', 'low ASCVD risk', 'moderate ASCVD risk'], 'conditions': ['Primary Hypercholesterolemia or Mixed Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.', 'detailedDescription': 'This study was designed as a randomized, double-blind, multi-center Phase III trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but \\< 190 mg/dL who were not on any lipid lowering therapy.\n\nThe study consisted of 3 parts:\n\n* Screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations.\n* Core Part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c.\n\n(inclisiran group) or matching placebo s.c. (control group) on Day 1 and Day 90. The end of core part (EOC) visit was conducted on Day 180. The database lock for the core part was planned to occur after all randomized participants have completed the EOC visit (or have discontinued from the study before EOC). The primary analysis was conducted after the database lock for the core part.\n\n• Extension Part: an extended treatment period of 180 days. In the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. The extension part was to start from the Day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.\n* Fasting LDL-C of ≥ 130 mg/dL but \\< 190 mg/dL\n* Triglycerides ≤ 400 mg/dL\n* Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline\n\nExclusion Criteria:\n\n* Use of any LLT within 90 days prior to screening visit\n* History of ASCVD\n* Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%\n* Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05888103', 'acronym': 'V-Mono China', 'briefTitle': 'Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol', 'orgStudyIdInfo': {'id': 'CKJX839D12305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inclisiran - Inclisiran', 'description': 'Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180', 'interventionNames': ['Drug: Inclisiran', 'Drug: Matching Placebo for Inclisiran']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo- Inclisiran', 'description': 'Placebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270', 'interventionNames': ['Drug: Inclisiran', 'Drug: Matching Placebo for Inclisiran']}], 'interventions': [{'name': 'Inclisiran', 'type': 'DRUG', 'otherNames': ['KJX839'], 'description': 'Inclisiran s.c', 'armGroupLabels': ['Inclisiran - Inclisiran', 'Placebo- Inclisiran']}, {'name': 'Matching Placebo for Inclisiran', 'type': 'DRUG', 'otherNames': ['Placebo s.c.'], 'description': 'Matching s.c. placebo', 'armGroupLabels': ['Inclisiran - Inclisiran', 'Placebo- Inclisiran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '528403', 'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410003', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '010017', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '213004', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '221003', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '330009', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '121001', 'city': 'Jinzhou', 'state': 'Liaoning', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.10778, 'lon': 121.14167}}, {'zip': '276000', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '030002', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710061', 'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Novartis Investigative Site'}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300121', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101200', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '250012', 'city': 'Jinan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300140', 'city': 'Tianjin', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/', '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. This 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'}}}}