Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-04-25 @ 12:42 AM
Study NCT ID:
NCT03011450
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603947', 'term': 'K-877 compound'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTGResults@KowaUS.com', 'phone': '919-433-1600', 'title': 'Director, Clinical Operations', 'organization': 'Kowa Research Institute, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 Weeks', 'description': 'Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.', 'eventGroups': [{'id': 'EG000', 'title': 'K-877: 12-Week Efficacy', 'description': '* K-877 0.2 mg Tablets BID\n* Only AEs with onset in the 12-week efficacy period are included.', 'otherNumAtRisk': 311, 'deathsNumAtRisk': 311, 'otherNumAffected': 0, 'seriousNumAtRisk': 311, 'deathsNumAffected': 3, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo:12-Week Efficacy', 'description': '* Placebo matching K-877 0.2 mg BID\n* Only AEs with onset in the 12-week efficacy period are included.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 0, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'K-877: 40-Week Extension', 'description': '* Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID in the 40-week Extension Period\n* Only AEs with onset in the 40-week extension period are included.', 'otherNumAtRisk': 292, 'deathsNumAtRisk': 292, 'otherNumAffected': 2, 'seriousNumAtRisk': 292, 'deathsNumAffected': 3, 'seriousNumAffected': 25}, {'id': 'EG003', 'title': 'Fenofibrate 40-Week Extension', 'description': '* Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.\n* Only AEs with onset in the 40-week extension period are included.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 8, 'seriousNumAtRisk': 154, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 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'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 311, 'numAffected': 1}, {'groupId': 'EG001', 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'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '17.52', 'groupId': 'OG000', 'lowerLimit': '-2.00', 'upperLimit': '39.87'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '-9.58', 'upperLimit': '17.69'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '44.20', 'groupId': 'OG000', 'lowerLimit': '10.67', 'upperLimit': '89.89'}, {'value': '4.81', 'groupId': 'OG001', 'lowerLimit': '-11.65', 'upperLimit': '25.30'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '53.94', 'groupId': 'OG000', 'lowerLimit': '14.68', 'upperLimit': '112.53'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '-16.31', 'upperLimit': '23.16'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '48.44', 'groupId': 'OG000', 'lowerLimit': '8.96', 'upperLimit': '110.09'}, {'value': '1.89', 'groupId': 'OG001', 'lowerLimit': '-14.54', 'upperLimit': '23.96'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '23.79', 'groupId': 'OG000', 'lowerLimit': '-19.17', 'upperLimit': '76.61'}, {'value': '-0.80', 'groupId': 'OG001', 'lowerLimit': '-13.28', 'upperLimit': '17.39'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.73', 'groupId': 'OG000', 'lowerLimit': '-48.62', 'upperLimit': '47.19'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '-21.79', 'upperLimit': '16.61'}]}]}], 'analyses': [{'pValue': '0.2763', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.48', 'groupId': 'OG000', 'lowerLimit': '-59.53', 'upperLimit': '7.01'}, 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[{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000', 'lowerLimit': '-10.90', 'upperLimit': '7.50'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-8.50', 'upperLimit': '9.19'}]}]}], 'analyses': [{'pValue': '0.1651', 'groupIds': 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In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.27', 'groupId': 'OG000', 'lowerLimit': '-79.42', 'upperLimit': '-9.78'}, {'value': '-9.13', 'groupId': 'OG001', 'lowerLimit': '-36.78', 'upperLimit': '26.18'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '-25.09', 'upperLimit': '20.86'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '-16.80', 'upperLimit': '20.72'}]}]}], 'analyses': [{'pValue': '0.5107', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '17.58', 'groupId': 'OG000', 'lowerLimit': '-13.32', 'upperLimit': '60.38'}, {'value': '4.97', 'groupId': 'OG001', 'lowerLimit': '-15.42', 'upperLimit': '25.30'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.06', 'groupId': 'OG000', 'lowerLimit': '-123.66', 'upperLimit': '39.24'}, {'value': '-2.74', 'groupId': 'OG001', 'lowerLimit': '-87.30', 'upperLimit': '76.76'}]}]}], 'analyses': [{'pValue': '0.0742', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '54.52', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '306.49'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-13.04', 'upperLimit': '43.85'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '83.88', 'groupId': 'OG000', 'lowerLimit': '-254.52', 'upperLimit': '394.98'}, {'value': '12.43', 'groupId': 'OG001', 'lowerLimit': '-135.98', 'upperLimit': '230.34'}]}]}], 'analyses': [{'pValue': '0.2707', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '5.96', 'groupId': 'OG000', 'lowerLimit': '-8.43', 'upperLimit': '23.02'}, {'value': '-1.60', 'groupId': 'OG001', 'lowerLimit': '-13.63', 'upperLimit': '11.21'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '-0.94', 'upperLimit': '1.56'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-1.02', 'upperLimit': '1.10'}]}]}], 'analyses': [{'pValue': '0.2879', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-3.98', 'upperLimit': '2.90'}, {'value': '-0.23', 'groupId': 'OG001', 'lowerLimit': '-2.96', 'upperLimit': '1.66'}]}]}], 'analyses': [{'pValue': '0.9786', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000', 'lowerLimit': '-2.95', 'upperLimit': '7.78'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '-4.19', 'upperLimit': '4.35'}]}]}], 'analyses': [{'pValue': '0.0075', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.02', 'groupId': 'OG000', 'lowerLimit': '-16.79', 'upperLimit': '5.79'}, {'value': '-2.26', 'groupId': 'OG001', 'lowerLimit': '-11.03', 'upperLimit': '7.60'}]}]}], 'analyses': [{'pValue': '0.0241', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.54'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.53', 'upperLimit': '0.54'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.19', 'groupId': 'OG000', 'lowerLimit': '-4.48', 'upperLimit': '2.36'}, {'value': '-0.14', 'groupId': 'OG001', 'lowerLimit': '-3.22', 'upperLimit': '2.36'}]}]}], 'analyses': [{'pValue': '0.0502', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.86', 'groupId': 'OG000', 'lowerLimit': '-70.90', 'upperLimit': '-31.38'}, {'value': '-15.24', 'groupId': 'OG001', 'lowerLimit': '-37.36', 'upperLimit': '18.69'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.19', 'groupId': 'OG000', 'lowerLimit': '-70.80', 'upperLimit': '-32.36'}, {'value': '-16.20', 'groupId': 'OG001', 'lowerLimit': '-37.74', 'upperLimit': '21.70'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '5.51', 'groupId': 'OG000', 'lowerLimit': '-12.73', 'upperLimit': '29.84'}, {'value': '-2.20', 'groupId': 'OG001', 'lowerLimit': '-17.16', 'upperLimit': '16.56'}]}]}], 'analyses': [{'pValue': '0.0209', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.21', 'groupId': 'OG000', 'lowerLimit': '-79.82', 'upperLimit': '-42.95'}, {'value': '-26.81', 'groupId': 'OG001', 'lowerLimit': '-51.86', 'upperLimit': '13.12'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.36', 'groupId': 'OG000', 'lowerLimit': '-47.83', 'upperLimit': '-10.34'}, {'value': '-9.02', 'groupId': 'OG001', 'lowerLimit': '-29.95', 'upperLimit': '6.61'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.36', 'groupId': 'OG000', 'lowerLimit': '-47.83', 'upperLimit': '-10.34'}, {'value': '-9.02', 'groupId': 'OG001', 'lowerLimit': '-29.95', 'upperLimit': '6.61'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.219', 'groupId': 'OG000', 'lowerLimit': '0.050', 'upperLimit': '0.359'}, {'value': '0.026', 'groupId': 'OG001', 'lowerLimit': '-0.096', 'upperLimit': '0.138'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'non-parametric Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'groupId': 'OG000', 'lowerLimit': '-19.68', 'upperLimit': '17.39'}, {'value': '-1.25', 'groupId': 'OG001', 'lowerLimit': '-13.68', 'upperLimit': '9.26'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching K-877 0.2 mg tablet BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.76', 'groupId': 'OG000', 'lowerLimit': '-45.35', 'upperLimit': '-7.99'}, {'value': '-0.47', 'groupId': 'OG001', 'lowerLimit': '-23.52', 'upperLimit': '17.90'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Hodges-Lehmann method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Fasting TG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.96', 'groupId': 'OG000', 'lowerLimit': '-74.38', 'upperLimit': '-41.52'}, {'value': '-49.55', 'groupId': 'OG001', 'lowerLimit': '-64.80', 'upperLimit': '-26.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Remnant Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.39', 'groupId': 'OG000', 'lowerLimit': '-72.45', 'upperLimit': '-39.62'}, {'value': '-43.31', 'groupId': 'OG001', 'lowerLimit': '-60.66', 'upperLimit': '-24.59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.78', 'groupId': 'OG000', 'lowerLimit': '3.03', 'upperLimit': '38.46'}, {'value': '15.59', 'groupId': 'OG001', 'lowerLimit': '5.26', 'upperLimit': '32.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '-6.51', 'upperLimit': '12.10'}, {'value': '2.56', 'groupId': 'OG001', 'lowerLimit': '-6.62', 'upperLimit': '12.31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.80', 'groupId': 'OG000', 'lowerLimit': '-37.89', 'upperLimit': '-6.95'}, {'value': '-14.22', 'groupId': 'OG001', 'lowerLimit': '-31.57', 'upperLimit': '3.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.28', 'groupId': 'OG000', 'lowerLimit': '-29.10', 'upperLimit': '-4.01'}, {'value': '-8.64', 'groupId': 'OG001', 'lowerLimit': '-23.55', 'upperLimit': '5.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.90', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '76.62'}, {'value': '22.96', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '51.68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in FFAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.61', 'groupId': 'OG000', 'lowerLimit': '-46.76', 'upperLimit': '8.15'}, {'value': '-21.41', 'groupId': 'OG001', 'lowerLimit': '-45.70', 'upperLimit': '-1.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo A2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.92', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '31.25'}, {'value': '8.33', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '20.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'groupId': 'OG000', 'lowerLimit': '-14.74', 'upperLimit': '15.84'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-14.13', 'upperLimit': '12.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo B48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.43', 'groupId': 'OG000', 'lowerLimit': '-58.77', 'upperLimit': '60.61'}, {'value': '-15.19', 'groupId': 'OG001', 'lowerLimit': '-51.08', 'upperLimit': '112.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo B100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.32', 'groupId': 'OG000', 'lowerLimit': '-15.58', 'upperLimit': '17.35'}, {'value': '-0.87', 'groupId': 'OG001', 'lowerLimit': '-13.44', 'upperLimit': '12.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo C2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.56', 'groupId': 'OG000', 'lowerLimit': '-34.50', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-19.81', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo C3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.80', 'groupId': 'OG000', 'lowerLimit': '-57.88', 'upperLimit': '-22.27'}, {'value': '-26.25', 'groupId': 'OG001', 'lowerLimit': '-44.64', 'upperLimit': '-2.73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Apo E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.82', 'groupId': 'OG000', 'lowerLimit': '-49.25', 'upperLimit': '-13.04'}, {'value': '-30.00', 'groupId': 'OG001', 'lowerLimit': '-42.59', 'upperLimit': '-9.76'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in FGF21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '371.80', 'groupId': 'OG000', 'lowerLimit': '97.30', 'upperLimit': '795.00'}, {'value': '194.40', 'groupId': 'OG001', 'lowerLimit': '57.00', 'upperLimit': '524.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.100', 'groupId': 'OG000', 'lowerLimit': '-1.400', 'upperLimit': '0.900'}, {'value': '-0.225', 'groupId': 'OG001', 'lowerLimit': '-1.700', 'upperLimit': '0.750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.60', 'groupId': 'OG000', 'lowerLimit': '-57.18', 'upperLimit': '-9.94'}, {'value': '-22.03', 'groupId': 'OG001', 'lowerLimit': '-46.31', 'upperLimit': '3.89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.03', 'groupId': 'OG000', 'lowerLimit': '-45.41', 'upperLimit': '-2.97'}, {'value': '-13.31', 'groupId': 'OG001', 'lowerLimit': '-32.85', 'upperLimit': '10.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.96', 'groupId': 'OG000', 'lowerLimit': '-28.26', 'upperLimit': '8.80'}, {'value': '-2.31', 'groupId': 'OG001', 'lowerLimit': '-21.61', 'upperLimit': '17.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '-22.32', 'upperLimit': '20.37'}, {'value': '3.54', 'groupId': 'OG001', 'lowerLimit': '-14.98', 'upperLimit': '19.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.33', 'groupId': 'OG000', 'lowerLimit': '-4.92', 'upperLimit': '45.07'}, {'value': '15.87', 'groupId': 'OG001', 'lowerLimit': '-3.79', 'upperLimit': '33.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.51', 'groupId': 'OG000', 'lowerLimit': '11.45', 'upperLimit': '96.51'}, {'value': '25.53', 'groupId': 'OG001', 'lowerLimit': '7.94', 'upperLimit': '57.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.36', 'groupId': 'OG000', 'lowerLimit': '18.02', 'upperLimit': '121.43'}, {'value': '33.66', 'groupId': 'OG001', 'lowerLimit': '8.36', 'upperLimit': '69.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.61', 'groupId': 'OG000', 'lowerLimit': '10.19', 'upperLimit': '110.03'}, {'value': '27.29', 'groupId': 'OG001', 'lowerLimit': '3.08', 'upperLimit': '75.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.50', 'groupId': 'OG000', 'lowerLimit': '-17.32', 'upperLimit': '76.72'}, {'value': '19.64', 'groupId': 'OG001', 'lowerLimit': '-9.16', 'upperLimit': '55.84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.92', 'groupId': 'OG000', 'lowerLimit': '-46.06', 'upperLimit': '44.10'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '-33.87', 'upperLimit': '37.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.63', 'groupId': 'OG000', 'lowerLimit': '-59.65', 'upperLimit': '4.76'}, {'value': '-24.80', 'groupId': 'OG001', 'lowerLimit': '-48.67', 'upperLimit': '7.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.26', 'groupId': 'OG000', 'lowerLimit': '-54.63', 'upperLimit': '-13.67'}, {'value': '-24.22', 'groupId': 'OG001', 'lowerLimit': '-46.23', 'upperLimit': '-7.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.81', 'groupId': 'OG000', 'lowerLimit': '-39.69', 'upperLimit': '-12.43'}, {'value': '-17.41', 'groupId': 'OG001', 'lowerLimit': '-34.43', 'upperLimit': '-3.23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.67', 'groupId': 'OG000', 'lowerLimit': '-21.85', 'upperLimit': '-0.44'}, {'value': '-5.62', 'groupId': 'OG001', 'lowerLimit': '-18.23', 'upperLimit': '5.91'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.62', 'groupId': 'OG000', 'lowerLimit': '-13.84', 'upperLimit': '5.23'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-13.22', 'upperLimit': '5.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '4.84'}, {'value': '1.54', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '3.24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.10', 'groupId': 'OG000', 'lowerLimit': '-63.62', 'upperLimit': '-14.91'}, {'value': '-28.98', 'groupId': 'OG001', 'lowerLimit': '-48.61', 'upperLimit': '-2.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.00', 'groupId': 'OG000', 'lowerLimit': '-32.70', 'upperLimit': '-2.40'}, {'value': '-8.60', 'groupId': 'OG001', 'lowerLimit': '-28.80', 'upperLimit': '-1.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.95', 'groupId': 'OG000', 'lowerLimit': '-77.20', 'upperLimit': '-5.10'}, {'value': '-26.90', 'groupId': 'OG001', 'lowerLimit': '-64.80', 'upperLimit': '4.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-18.10', 'upperLimit': '19.60'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-16.60', 'upperLimit': '24.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.43', 'groupId': 'OG000', 'lowerLimit': '-10.07', 'upperLimit': '62.78'}, {'value': '12.79', 'groupId': 'OG001', 'lowerLimit': '-11.69', 'upperLimit': '43.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.00', 'groupId': 'OG000', 'lowerLimit': '-151.00', 'upperLimit': '53.00'}, {'value': '-6.00', 'groupId': 'OG001', 'lowerLimit': '-127.00', 'upperLimit': '57.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '273.00'}, {'value': '8.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '199.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.00', 'groupId': 'OG000', 'lowerLimit': '-198.00', 'upperLimit': '425.00'}, {'value': '97.00', 'groupId': 'OG001', 'lowerLimit': '-209.00', 'upperLimit': '420.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.96', 'groupId': 'OG000', 'lowerLimit': '-9.59', 'upperLimit': '20.58'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-9.74', 'upperLimit': '13.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '1.50'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '1.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-3.70', 'upperLimit': '2.80'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-4.20', 'upperLimit': '2.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '-2.90', 'upperLimit': '7.30'}, {'value': '1.40', 'groupId': 'OG001', 'lowerLimit': '-2.70', 'upperLimit': '5.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.15', 'groupId': 'OG000', 'lowerLimit': '-17.67', 'upperLimit': '3.71'}, {'value': '-5.46', 'groupId': 'OG001', 'lowerLimit': '-15.32', 'upperLimit': '3.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.57'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '2.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-4.35', 'upperLimit': '2.27'}, {'value': '-1.15', 'groupId': 'OG001', 'lowerLimit': '-4.35', 'upperLimit': '1.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.03', 'groupId': 'OG000', 'lowerLimit': '-73.79', 'upperLimit': '-31.24'}, {'value': '-42.76', 'groupId': 'OG001', 'lowerLimit': '-58.82', 'upperLimit': '-13.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.30', 'groupId': 'OG000', 'lowerLimit': '-73.74', 'upperLimit': '-30.73'}, {'value': '-41.55', 'groupId': 'OG001', 'lowerLimit': '-58.97', 'upperLimit': '-17.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '-15.75', 'upperLimit': '24.94'}, {'value': '-1.19', 'groupId': 'OG001', 'lowerLimit': '-15.14', 'upperLimit': '25.57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.38', 'groupId': 'OG000', 'lowerLimit': '-81.70', 'upperLimit': '-45.55'}, {'value': '-56.61', 'groupId': 'OG001', 'lowerLimit': '-71.34', 'upperLimit': '-32.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.53', 'groupId': 'OG000', 'lowerLimit': '-47.32', 'upperLimit': '-13.74'}, {'value': '-23.70', 'groupId': 'OG001', 'lowerLimit': '-41.03', 'upperLimit': '-5.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.49', 'groupId': 'OG000', 'lowerLimit': '-53.81', 'upperLimit': '-16.78'}, {'value': '-27.67', 'groupId': 'OG001', 'lowerLimit': '-47.17', 'upperLimit': '-7.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.210', 'groupId': 'OG000', 'lowerLimit': '0.050', 'upperLimit': '0.420'}, {'value': '0.150', 'groupId': 'OG001', 'lowerLimit': '0.030', 'upperLimit': '0.310'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.56', 'groupId': 'OG000', 'lowerLimit': '-20.00', 'upperLimit': '14.91'}, {'value': '-2.94', 'groupId': 'OG001', 'lowerLimit': '-19.27', 'upperLimit': '10.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'OG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.81', 'groupId': 'OG000', 'lowerLimit': '-43.96', 'upperLimit': '-4.95'}, {'value': '-13.17', 'groupId': 'OG001', 'lowerLimit': '-32.52', 'upperLimit': '4.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'K-877', 'description': 'Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID in the 40-week Extension Period'}, {'id': 'FG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}], 'periods': [{'title': '12-week Efficacy', 'milestones': [{'type': 'STARTED', 'comment': 'One participant was randomized but not assigned to a treatment group per physician decision.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '40-week Extension', 'milestones': [{'type': 'STARTED', 'comment': 'Note that 12 participants (7 participants in the K-877 group and 5 participants in the placebo/fenofibrate group) withdrew after completing the 12-week Efficacy Period and did not start the 40-week Extension Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': "Eligible patients entered a 4- to 6-week lifestyle stabilization period. The stabilization period was followed by a 2-week TG qualifying period, and patient eligibility was assessed based on the mean TG value from these 2 visits. If the patient's mean TG level during the TG qualifying period was ≥450 mg/dL (5.09 mmol/L) and \\<500 mg/dL (5.65 mmol/L), an additional TG measurement was taken 1 week later at Visit 3.1. The mean of all 3 TG measurements was used to determine eligibility for the study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'K-877', 'description': 'K-877 0.2 mg Tablets'}, {'id': 'BG001', 'title': 'Placebo/Fenofibrate', 'description': 'Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}]}, {'title': 'Not reported/unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '793.44', 'spread': '390.102', 'groupId': 'BG000'}, {'value': '759.36', 'spread': '395.359', 'groupId': 'BG001'}, {'value': '781.45', 'spread': '391.511', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One participant was randomized but not assigned to a treatment group per physician decision'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-13', 'size': 801317, 'label': 'Study Protocol: Ver.1.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-08T16:27', 'hasProtocol': True}, {'date': '2017-08-25', 'size': 1329918, 'label': 'Study Protocol: Ver.2.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-08T16:28', 'hasProtocol': True}, {'date': '2016-10-19', 'size': 467235, 'label': 'Statistical Analysis Plan: V1.0', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-08T16:28', 'hasProtocol': False}, {'date': '2019-06-21', 'size': 470807, 'label': 'Statistical Analysis Plan: V2.0', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-08T16:29', 'hasProtocol': False}, {'date': '2019-10-21', 'size': 296640, 'label': 'Statistical Analysis Plan: Addendum', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-08T16:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 471}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2020-04-22', 'completionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2016-12-20', 'dispFirstSubmitQcDate': '2020-04-27', 'resultsFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2017-01-04', 'dispFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-30', 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Fasting TG From Baseline to Week 12', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Remnant Cholesterol', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in HDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo A1', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Non-HDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Total Cholesterol', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in LDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in FFAs', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo A2', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo B', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo B48', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo B100', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo C2', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo C3', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Apo E', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in FGF21', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in hsCRP', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)', 'timeFrame': '12 Weeks', 'description': 'Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.'}, {'measure': 'Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)', 'timeFrame': '12 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)', 'timeFrame': '12 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)', 'timeFrame': '12 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C', 'timeFrame': '12 Weeks'}, {'measure': 'Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2', 'timeFrame': '12 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Fasting TG', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Remnant Cholesterol', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in HDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo A1', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Non-HDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in TC', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in LDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in FFAs', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo A2', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo B', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo B48', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo B100', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo C2', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo C3', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo E', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in FGF21', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in hsCRP', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)', 'timeFrame': '52 Weeks', 'description': 'Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.'}, {'measure': 'Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)', 'timeFrame': '52 Weeks', 'description': 'Two types of lipoprotein particles were analyzed together as one measurement without distinction.'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C', 'timeFrame': '52 Weeks'}, {'measure': 'Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1', 'timeFrame': '52 Weeks'}, {'measure': 'Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2', 'timeFrame': '52 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and \\<2000 mg/dL and Mild or Moderate Renal Impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;\n2. Aged ≥18 years;\n3. Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):\n\n 1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack \\[TIA\\] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);\n 2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);\n 3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or\n 4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;\n4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria;\n\n 1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.);\n 2. Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or\n 3. Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;\n5. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and \\<2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).\n\n * Mild to moderate renal impairment eGFR \\>= 30mL/min/1.73 and \\< 90 mL/min/1.73 at Visit 1\n\nExclusion Criteria:\n\n1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (\\>100 mg/day), omega-3 fatty acids (\\>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;\n2. Body mass index (BMI) \\>45 kg/m2 at Visit 1 (Week -8 or Week -6);\n3. Patients with type 1 diabetes mellitus;\n4. Patients with newly diagnosed (within 3 months prior to Visit 2 \\[Week -2\\]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c \\>9.5% at Visit 1 (Week -8 or Week -6);'}, 'identificationModule': {'nctId': 'NCT03011450', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment', 'orgStudyIdInfo': {'id': 'K-877-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '12 Week Efficacy', 'description': 'K-877 or placebo comparator for 12 weeks', 'interventionNames': ['Drug: K-877', 'Drug: Placebo (for K-877)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '40 week extension', 'description': 'K-877 or fenofibrate comparator for 40 weeks', 'interventionNames': ['Drug: K-877', 'Drug: Fenofibrate']}], 'interventions': [{'name': 'K-877', 'type': 'DRUG', 'armGroupLabels': ['12 Week Efficacy', '40 week extension']}, {'name': 'Fenofibrate', 'type': 'DRUG', 'armGroupLabels': ['40 week extension']}, {'name': 'Placebo (for K-877)', 'type': 'DRUG', 'armGroupLabels': ['12 Week Efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Alabama Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35570', 'city': 'Hamilton', 'state': 'Alabama', 'country': 'United States', 'facility': 'Boyett Health Services Inc', 'geoPoint': {'lat': 34.14232, 'lon': -87.98864}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Longwood Research - Saadat Ansari, MD, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35674', 'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Terence T. 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