Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04987320
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2021-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723009', 'term': 'olpasiran'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 225 days', 'description': 'Safety Analysis Set: included all randomized participants who received olpasiran.', 'eventGroups': [{'id': 'EG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dental restoration failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fracture pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'spread': '55.5', 'groupId': 'OG000'}, {'value': '549', 'spread': '71.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2660', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '12000', 'spread': '41.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2660', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '12000', 'spread': '41.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '2.85', 'upperLimit': '9.00'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '2.88', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Half-life (T1/2) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.05', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '238', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '176', 'spread': '60.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CL/F) of Olpasiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '41.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 225', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. 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'9.52', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '9.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '2.17', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '0.879', 'spread': '7.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 155', 'categories': [{'measurements': [{'value': '1.20', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '0.689', 'spread': '8.03', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up (Day 225)', 'categories': [{'measurements': [{'value': '6.95', 'spread': '9.43', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '8.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.', 'unitOfMeasure': 'percentage change in total cholesterol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '2.86', 'spread': '9.63', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '9.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '8.10', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '7.95', 'spread': '8.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '0.185', 'spread': '8.20', 'groupId': 'OG000'}, {'value': '-0.294', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 155', 'categories': [{'measurements': [{'value': '11.4', 'spread': '9.46', 'groupId': 'OG000'}, {'value': '9.31', 'spread': '9.47', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up (Day 225)', 'categories': [{'measurements': [{'value': '18.1', 'spread': '8.27', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.', 'unitOfMeasure': 'percentage change in ApoA1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein B (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.0576', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '7.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.65', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '9.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '3.66', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '8.49', 'groupId': 'OG001'}]}]}, {'title': 'Day 155', 'categories': [{'measurements': [{'value': '-0.834', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '-0.958', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up (Day 225)', 'categories': [{'measurements': [{'value': '5.64', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.', 'unitOfMeasure': 'percentage change in Apo B', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Lipoprotein-a (Lp[a])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'OG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.245', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '-0.295', 'spread': '9.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.93', 'spread': 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'11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75.8', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '-93.7', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.3', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '-89.1', 'spread': '8.17', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up (Day 225)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.1', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '-81.5', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.', 'unitOfMeasure': 'percentage change in Lp(a)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'FG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olpasiran Low Dose', 'description': 'Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.'}, {'id': 'BG001', 'title': 'Olpasiran High Dose', 'description': 'Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 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{'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'}], 'populationDescription': 'Safety Analysis Set: included all randomized participants who received olpasiran.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-28', 'size': 2822957, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-08T13:58', 'hasProtocol': True}, {'date': '2022-12-06', 'size': 959163, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-08T13:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2021-07-26', 'resultsFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-20', 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Time to Cmax (Tmax) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Apparent Terminal Elimination Half-life (T1/2) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Apparent Total Body Clearance (CL/F) of Olpasiran', 'timeFrame': 'Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85', 'description': 'The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.'}, {'measure': 'Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 225', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as an AE that starts on or after the first dose of investigational product and up to end of study.\n\nClinically significant changes in clinical laboratory tests, 12-lead electrocardiograms, and vital signs were reported as AEs.'}, {'measure': 'Percentage Change From Baseline in Triglycerides', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Total Cholesterol', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline and Days 7, 15, 57, 155 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}, {'measure': 'Percentage Change From Baseline in Lipoprotein-a (Lp[a])', 'timeFrame': 'Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225', 'description': 'Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elevated serum lipoprotein(a)', 'Olpasiran'], 'conditions': ['Elevated Serum Lipoprotein(a)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp\\[a\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion eligibility criteria will be evaluated in 2 parts during the screening period:\n\n* Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.\n* Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.\n\nPart 1:\n\n* Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry.\n* Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening.\n* Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).\n\nPart 2:\n\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \\[e.g., suspicion of Gilbert\'s syndrome based on total and direct bilirubin\\] is not acceptable) as assessed by the Investigator (or designee).\n* Body mass index between 18 and 32 kg/m\\^2 (inclusive) at the time of Screening.\n* Subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose (i.e., no change in medication or dosage) for the duration of the study.\n* Females must be of non-reproductive potential:\n\n a. Postmenopausal defined as: i. Age of ≥ 55 years with no menses for at least 12 months; OR ii. Age of \\< 55 years with no menses for at least 12 months AND with a follicle stimulating hormone (FSH) level \\> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR b. History of hysterectomy; OR c. History of bilateral oophorectomy.\n\nExclusion Criteria:\n\n* History or clinical evidence of peripheral neuropathy.\n* Currently receiving apheresis as lipid reducing therapy.\n* History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory\'s normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory\'s normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.\n* History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening.\n* Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils \\> 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT04987320', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Subjects With Elevated Serum Lipoprotein(a)', 'orgStudyIdInfo': {'id': '20190095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olpasiran Dose A', 'description': 'Participants will be administered Olpasiran dose A as a subcutaneous injection.', 'interventionNames': ['Drug: Olpasiran']}, {'type': 'EXPERIMENTAL', 'label': 'Olpasiran Dose B', 'description': 'Participants will be administered Olpasiran dose B as a subcutaneous injection.', 'interventionNames': ['Drug: Olpasiran']}], 'interventions': [{'name': 'Olpasiran', 'type': 'DRUG', 'otherNames': ['AMG 890'], 'description': 'Subcutaneous injection', 'armGroupLabels': ['Olpasiran Dose A', 'Olpasiran Dose B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'HK', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}