Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03514420
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2018-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D052496', 'term': 'Lipodystrophy, Familial Partial'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003923', 'term': 'Diabetes Mellitus, Lipoatrophic'}], 'ancestors': [{'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalstudies@akceatx.com', 'phone': '617-207-0289', 'title': 'Study Director', 'organization': 'Akcea Therapeutics'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent to end of follow up period (Up to week 40)', 'description': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by subcutaneous (SC) injection.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Albumin urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Antinuclear antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Creatinine urine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Insulin C-peptide decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urine albumin/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'urinary casts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Mean cell haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Mean cell volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Crystal urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Liver function test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides Levels at End of the Treatment (Week 27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.9', 'spread': '26.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Area Under the Curve (AUC) of Plasma Glucose as Assessed by Mixed Meal Test (MMT) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9815.0', 'spread': '4071.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the area under the curve (AUC) of Plasma Glucose was assessed.', 'unitOfMeasure': 'mg/dL*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Serum Insulin as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '3262.0', 'spread': '3775.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum Insulin was assessed.', 'unitOfMeasure': 'milli international units per liter*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Serum C-peptide as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-192.3', 'spread': '257.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum C-peptide was assessed.', 'unitOfMeasure': 'ng/mL*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Free Fatty Acid (FFA) as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.0', 'spread': '42.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of FFA was assessed.', 'unitOfMeasure': 'mEq/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Serum Ghrelin as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '8479.5', 'spread': '7241.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum Ghrelin was assessed.', 'unitOfMeasure': 'pg/mL*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Incretin Hormone (Gastric Inhibitory Polypeptide [GIP]) as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1694.7', 'spread': '11752.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Incretin Hormone: GIP was assessed.', 'unitOfMeasure': 'pg/mL*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Incretin Hormone (Glucagon-like Peptide -1 [GLP-1]) as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1677.3', 'spread': '11301.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Incretin Hormone: GLP-1 was assessed.', 'unitOfMeasure': 'pmol/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC of Peptide Tyrosine Tyrosine (PYY) as Assessed by MMT at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '6549.0', 'spread': '10632.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of PYY was assessed.', 'unitOfMeasure': 'pg/mL*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HDL-C at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '6.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': 'NA', 'comment': 'Due to a single analyzed participant, standard deviation was not calculated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. LDL-C calculated using ultracentrifugation method.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol (TC) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.3', 'spread': '32.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VLDL-C at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.0', 'spread': 'NA', 'comment': 'Due to a single analyzed participant, standard deviation was not calculated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. VLDL-C was calculated using direct test method.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-HDL-C at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.4', 'spread': '34.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoB at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '25.265', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoB-48 at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.601', 'spread': '1.3284', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein B 100 (ApoB-100) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.433', 'spread': '24.6001', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoA-1 at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.8', 'spread': '22.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoC-III at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.555', 'spread': '9.1220', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoC-III: Chylomicron at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available as the collected Baseline samples were not sufficient to assess this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoC-III: VLDL at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available as the collected Baseline samples were not sufficient to assess this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoC-III: LDL at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.110', 'spread': 'NA', 'comment': 'Due to a single analyzed participant, standard deviation was not calculated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ApoC-III: HDL at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.904', 'spread': '5.9174', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipoprotein a (Lp[a]) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '14.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'nanomoles per liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Free Fatty Acid (FFA) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5779', 'spread': '0.8778', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycerol Levels at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.0', 'spread': '3.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'micromoles per liter (μmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipoprotein Particle Size at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'title': 'HDL Size', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'LDL Size', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'VLDL Size', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '7.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment. Lipoprotein Particle size included: HDL size, LDL size and VLDL size.', 'unitOfMeasure': 'nanometer (nm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.991', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last non-missing assessment prior to the first dose of study drug.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants, data for this outcome measure was not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Adiponectin at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.742', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment.', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in and Leptin at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.650', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hepatic Fat Fraction (HFF) as Assessed by Magnetic Resonance Imaging (MRI) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1400', 'spread': '6.1107', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last non-missing assessment prior to the first dose of study drug.', 'unitOfMeasure': 'percentage of hepatic fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Fat Distribution for Various Areas in the Body as Measured by Skinfold Thickness at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'title': 'Right Anterior Thigh Skinfold Thickness', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Right Tricep Skinfold Thickness', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug. Change in body fat distribution was measured as right anterior thigh skinfold thickness and right tricep skinfold thickness by Skinfold Thickness.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Fat Distribution for Various Areas in the Body as Measured by Dual-Energy X-ray Absorptiometry (DEXA) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'title': 'Arm Bone Mass', 'categories': [{'measurements': [{'value': '11.3', 'spread': '19.86', 'groupId': 'OG000'}]}]}, {'title': 'Arm Fat Mass', 'categories': [{'measurements': [{'value': '603.8', 'spread': '803.36', 'groupId': 'OG000'}]}]}, {'title': 'Arm Lean Mass', 'categories': [{'measurements': [{'value': '273.3', 'spread': '612.04', 'groupId': 'OG000'}]}]}, {'title': 'Arm Total Mass', 'categories': [{'measurements': [{'value': '875.0', 'spread': '1384.14', 'groupId': 'OG000'}]}]}, {'title': 'Leg Bone Mass', 'categories': [{'measurements': [{'value': '16.5', 'spread': '40.53', 'groupId': 'OG000'}]}]}, {'title': 'Leg Fat Mass', 'categories': [{'measurements': [{'value': '436.8', 'spread': '662.80', 'groupId': 'OG000'}]}]}, {'title': 'Leg Lean Mass', 'categories': [{'measurements': [{'value': '-345.8', 'spread': '1384.52', 'groupId': 'OG000'}]}]}, {'title': 'Leg Total Mass', 'categories': [{'measurements': [{'value': '125.0', 'spread': '1736.62', 'groupId': 'OG000'}]}]}, {'title': 'Total Bone Mass', 'categories': [{'measurements': [{'value': '37.3', 'spread': '77.03', 'groupId': 'OG000'}]}]}, {'title': 'Total Fat Mass', 'categories': [{'measurements': [{'value': '1197.3', 'spread': '1667.27', 'groupId': 'OG000'}]}]}, {'title': 'Total Lean Mass', 'categories': [{'measurements': [{'value': '-891.5', 'spread': '1852.25', 'groupId': 'OG000'}]}]}, {'title': 'Total Total Mass', 'categories': [{'measurements': [{'value': '350.0', 'spread': '3183.81', 'groupId': 'OG000'}]}]}, {'title': 'Trunk Bone Mass', 'categories': [{'measurements': [{'value': '23.3', 'spread': '35.37', 'groupId': 'OG000'}]}]}, {'title': 'Trunk Fat Mass', 'categories': [{'measurements': [{'value': '183.5', 'spread': '296.49', 'groupId': 'OG000'}]}]}, {'title': 'Trunk Lean Mass', 'categories': [{'measurements': [{'value': '-728.8', 'spread': '590.17', 'groupId': 'OG000'}]}]}, {'title': 'Trunk Total Mass', 'categories': [{'measurements': [{'value': '-500.0', 'spread': '836.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Screening assessment. Change in body fat distribution (arm bone mass, arm fat mass, arm lean mass, arm total mass, leg bone mass, leg fat mass, leg lean mass, leg total mass, total bone mass, total fat mass, total lean mass, total total mass , trunk bone mass, trunk fat mass, trunk lean mass and trunk total mass) was measures obtained from DEXA.', 'unitOfMeasure': 'gram (g)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Fat Distribution for Total Bone Mineral Density in the Body as Measured by Dual-Energy X-ray Absorptiometry (DEXA) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as Screening assessment. Change in body fat distribution for total Bone mineral density was measures obtained from DEXA.', 'unitOfMeasure': 'gram per centimeter square (g/cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visceral Adipose Tissue (VAT) as Measured by Magnetic Resonance Imaging (MRI) at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants, data for this outcome measure was not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subcutaneous Adipose Tissue (SAT) as MRI at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants, data for this outcome measure was not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '3.309', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose assessment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.88', 'spread': '1.863', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Screening assessment.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist/Hip Ratio at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as screening assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants, data for this outcome measure was not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'title': 'Severity of fatigue', 'categories': [{'title': 'Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Severity of trouble thinking or remembering', 'categories': [{'title': 'Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Severity of waking up tired', 'categories': [{'title': 'Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the screening assessment. Quality of life measures the severity of fatigue, severity of trouble thinking or remembering and severity of waking up tired in participants, on a scale ranging from 0 to 3, where, 0= No problem, 1= Mild, 2= Moderate and 3= severe. Higher scores indicates more severity or more impact on quality of life.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Score at End of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '3.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as a Screening assessment. Pain score is used to determine disease activity in participants, on a scale ranging from 0 to 5 where 0= never, 1= hardly noticed, 2= slightly, 3= moderately, 4= strongly, and 5= very strongly where higher scores indicated higher degree of pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing of informed consent to end of follow up period (Up to week 40)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. "A treatment-emergent adverse event (TEAE) is defined as any AE starting on or after the first dose of the study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by subcutaneous (SC) injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a single center in the United States of America from 15 June 2018 to 21 August 2019.', 'preAssignmentDetails': 'A total of 8 participants diagnosed with familial partial lipodystrophy (FPL) were screened, out of which 4 participants were treated with AKCEA-ANGPTL3-LRx 20 milligrams (mg). All 4 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.3', 'spread': '3.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Triglycerides (TG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '817.8', 'spread': '431.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Apolipoprotein B-48 (Apo B-48)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.109', 'spread': '0.5588', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Apolipoprotein C-III (Apo CIII)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.435', 'spread': '11.8481', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Apolipoprotein B (ApoB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '124.95', 'spread': '24.972', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '223.4', 'spread': '22.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting High Density Lipoprotein- Cholesterol (HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.13', 'spread': '3.473', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Apolipoprotein A-I (Apo A-1)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '121.3', 'spread': '9.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Very low Density Lipoprotein-Cholesterol (VLDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '130.3', 'spread': '22.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'VLDL-C calculated using direct test method.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for fasting VLDL-C.'}, {'title': 'Fasting Low Density Lipoprotein Cholesterol (LDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '24.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'LDL-C calculated using ultracentrifugation method.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for fasting LDL-C.'}, {'title': 'Area Under Curve (AUC) of Plasma Glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '257', 'spread': '45.2622', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligram/deciliter*minute (mg/dL*min)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC of Serum Insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.625', 'spread': '4.852748', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milli international units/ liter*minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC of Serum C-peptide', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.266', 'spread': '1.234', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nanogram/milliliter*minute (ng/mL*min)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for AUC of Serum C-peptide.'}, {'title': 'AUC of Free Fatty Acid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.458', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milliequivalents/liter*min (mEq/L*min)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for AUC of Free fatty acid.'}, {'title': 'AUC of Gastric Inhibitory Polypeptide (GIP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.02', 'spread': '38.555', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'picograms/milliliter*minute (pg/mL*min)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for AUC of GIP.'}, {'title': 'AUC of Glucagon-like Peptide 1 (GLP-1)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.35', 'spread': '17.065', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'picomoles/liter*minute (pmol/L*min)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed signifies the number of participants with data available for AUC of GLP-1.'}, {'title': 'AUC of Peptide Tyrosine Tyrosine (PYY)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '80.412', 'spread': '99.559', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL*min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC of Serum Ghrelin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.955', 'spread': '15.127', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL*min', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety set included all participants who were enrolled and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-16', 'size': 2684875, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-06T10:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2018-04-21', 'resultsFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2018-04-21', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-27', 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Fasting Triglycerides Levels at End of the Treatment (Week 27)', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Area Under the Curve (AUC) of Plasma Glucose as Assessed by Mixed Meal Test (MMT) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the area under the curve (AUC) of Plasma Glucose was assessed.'}, {'measure': 'Change From Baseline in AUC of Serum Insulin as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum Insulin was assessed.'}, {'measure': 'Change From Baseline in AUC of Serum C-peptide as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum C-peptide was assessed.'}, {'measure': 'Change From Baseline in AUC of Free Fatty Acid (FFA) as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of FFA was assessed.'}, {'measure': 'Change From Baseline in AUC of Serum Ghrelin as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Serum Ghrelin was assessed.'}, {'measure': 'Change From Baseline in AUC of Incretin Hormone (Gastric Inhibitory Polypeptide [GIP]) as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Incretin Hormone: GIP was assessed.'}, {'measure': 'Change From Baseline in AUC of Incretin Hormone (Glucagon-like Peptide -1 [GLP-1]) as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of Incretin Hormone: GLP-1 was assessed.'}, {'measure': 'Change From Baseline in AUC of Peptide Tyrosine Tyrosine (PYY) as Assessed by MMT at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'Change from Baseline to Week 27 in the AUC of PYY was assessed.'}, {'measure': 'Change From Baseline in HDL-C at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in LDL-C at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. LDL-C calculated using ultracentrifugation method.'}, {'measure': 'Change From Baseline in Total Cholesterol (TC) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in VLDL-C at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. VLDL-C was calculated using direct test method.'}, {'measure': 'Change From Baseline in Non-HDL-C at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoB at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoB-48 at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Apolipoprotein B 100 (ApoB-100) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoA-1 at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoC-III at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoC-III: Chylomicron at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoC-III: VLDL at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoC-III: LDL at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in ApoC-III: HDL at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Lipoprotein a (Lp[a]) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Free Fatty Acid (FFA) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Glycerol Levels at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Lipoprotein Particle Size at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment. Lipoprotein Particle size included: HDL size, LDL size and VLDL size.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last non-missing assessment prior to the first dose of study drug.'}, {'measure': 'Change From Baseline in Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in Adiponectin at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment.'}, {'measure': 'Change From Baseline in and Leptin at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose fasting assessment'}, {'measure': 'Change From Baseline in Hepatic Fat Fraction (HFF) as Assessed by Magnetic Resonance Imaging (MRI) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last non-missing assessment prior to the first dose of study drug.'}, {'measure': 'Changes From Baseline in Body Fat Distribution for Various Areas in the Body as Measured by Skinfold Thickness at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug. Change in body fat distribution was measured as right anterior thigh skinfold thickness and right tricep skinfold thickness by Skinfold Thickness.'}, {'measure': 'Changes From Baseline in Body Fat Distribution for Various Areas in the Body as Measured by Dual-Energy X-ray Absorptiometry (DEXA) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Screening assessment. Change in body fat distribution (arm bone mass, arm fat mass, arm lean mass, arm total mass, leg bone mass, leg fat mass, leg lean mass, leg total mass, total bone mass, total fat mass, total lean mass, total total mass , trunk bone mass, trunk fat mass, trunk lean mass and trunk total mass) was measures obtained from DEXA.'}, {'measure': 'Changes From Baseline in Body Fat Distribution for Total Bone Mineral Density in the Body as Measured by Dual-Energy X-ray Absorptiometry (DEXA) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as Screening assessment. Change in body fat distribution for total Bone mineral density was measures obtained from DEXA.'}, {'measure': 'Change From Baseline in Visceral Adipose Tissue (VAT) as Measured by Magnetic Resonance Imaging (MRI) at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug.'}, {'measure': 'Change From Baseline in Subcutaneous Adipose Tissue (SAT) as MRI at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the last assessment prior to the first dose of study drug.'}, {'measure': 'Change From Baseline in Body Weight at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Day 1 pre-dose assessment.'}, {'measure': 'Change From Baseline in Waist Circumference at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the Screening assessment.'}, {'measure': 'Change From Baseline in Waist/Hip Ratio at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as screening assessment.'}, {'measure': 'Change From Baseline in Quality of Life (QoL)', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as the screening assessment. Quality of life measures the severity of fatigue, severity of trouble thinking or remembering and severity of waking up tired in participants, on a scale ranging from 0 to 3, where, 0= No problem, 1= Mild, 2= Moderate and 3= severe. Higher scores indicates more severity or more impact on quality of life.'}, {'measure': 'Change From Baseline in Pain Score at End of the Treatment', 'timeFrame': 'Baseline and End of the Treatment (Week 27)', 'description': 'The baseline was defined as a Screening assessment. Pain score is used to determine disease activity in participants, on a scale ranging from 0 to 5 where 0= never, 1= hardly noticed, 2= slightly, 3= moderately, 4= strongly, and 5= very strongly where higher scores indicated higher degree of pain.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From signing of informed consent to end of follow up period (Up to week 40)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. "A treatment-emergent adverse event (TEAE) is defined as any AE starting on or after the first dose of the study drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lipodystrophy', 'Lipodystrophy, Familial Partial', 'Lipid Metabolism Disorders', 'Dyslipidemias', 'Kobberling-Dunnigan syndrome (type 1 and 2)', 'Lipoatrophic Diabetes'], 'conditions': ['Familial Partial Lipodystrophy']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of fasting triglycerides in participants with familial partial lipodystrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must give written informed consent to participate in the study.\n* Clinical diagnosis of familial partial lipodystrophy plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia.\n* Diagnosis of diabetes mellitus, made at least 6 months prior to the Screening with hemoglobin A1c (HbA1c) ≥ 7% to ≤ 12% at Screening and on anti-diabetic therapy as defined in study protocol.\n* Hypertriglyceridemia as defined by fasting triglycerides (TG) levels ≥ 500 milligrams per deciliter (mg/dL) at both Screening and Qualification visits. Participants with the clinical diagnosis of FPL and with fasting TG levels ≥ 200 (≥ 2.26 millimoles per liter \\[mmol/L\\]) to \\< 500 mg/dL (≥ 5.7 mmol/L) who meet the genetic or family history criteria for study inclusion may be further screened and enrolled in the study.\n* Presence of hepatosteatosis (fatty liver), as evidenced by a Screening magnetic resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%.\n\nKey Exclusion Criteria:\n\n* Diagnosis of generalized lipodystrophy.\n* Diagnosis of acquired partial lipodystrophy (APL).\n* Acute pancreatitis within 4 weeks of Screening.\n* Acute coronary syndrome within 6 months of Screening.\n* Major surgery within 3 months of Screening.\n* Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study.'}, 'identificationModule': {'nctId': 'NCT03514420', 'briefTitle': 'Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akcea Therapeutics'}, 'officialTitle': 'An Open-label Phase 2 Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Familial Partial Lipodystrophy', 'orgStudyIdInfo': {'id': 'ISIS 703802-CS5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKCEA-ANGPTL3-LRx 20 mg', 'description': 'Participants received AKCEA-ANGPTL3-LRx 20 milligrams (mg) administered every week for 26 weeks by subcutaneous (SC) injection.', 'interventionNames': ['Drug: AKCEA-ANGPTL3-LRx']}], 'interventions': [{'name': 'AKCEA-ANGPTL3-LRx', 'type': 'DRUG', 'otherNames': ['ISIS 703802'], 'description': 'AKCEA-ANGPTL3-LRx solution for SC injection.', 'armGroupLabels': ['AKCEA-ANGPTL3-LRx 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akcea Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}