Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-31 @ 1:34 PM
Study NCT ID:
NCT02714569
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2016-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to End of Study (Up to 10 Weeks)', 'description': 'The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1 mg LY3202328 (LY)', 'description': '1 mg of LY was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '5 mg LY', 'description': '5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '20 mg LY', 'description': '20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '30 mg LY Fed', 'description': '30 mg of LY (fed) was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '100 mg LY', 'description': '100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': '300 mg LY', 'description': '300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': '600 mg of LY', 'description': '600 mg of LY was taken orally in one of four periods in Part A.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alt increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pr interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stiff neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatographic urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flushed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'Participants were randomly assigned to placebo instead of LY in one of the first three periods.'}, {'id': 'OG001', 'title': 'Part A: 1 mg LY3202328 (LY)', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 30 mg LY Fed', 'description': '30 mg (fed) of LY was taken orally in one of four periods.'}, {'id': 'OG008', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}, {'id': 'OG009', 'title': 'Part B: SS/AS/Placebo', 'description': 'Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG010', 'title': 'Part B: SS/AS/5 mg of LY', 'description': '5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG011', 'title': 'Part B: SS/AS/20 mg of LY', 'description': '20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG012', 'title': 'Part B: SS/AS/100 mg of LY', 'description': '100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG013', 'title': 'Part B: SS/AS/300 mg of LY', 'description': '300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 42 Days', 'description': 'Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG001', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 30 mg LY Fed', 'description': '30 mg of LY (fed) was taken orally in one of four periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.258', 'spread': '21.11', 'groupId': 'OG000'}, {'value': '105.023', 'spread': '26.66', 'groupId': 'OG001'}, {'value': '340.829', 'spread': '28.99', 'groupId': 'OG002'}, {'value': '581.782', 'spread': '32.29', 'groupId': 'OG003'}, {'value': '1600.953', 'spread': '40.01', 'groupId': 'OG004'}, {'value': '1632.595', 'spread': '42.84', 'groupId': 'OG005'}, {'value': '2866.855', 'spread': '51.29', 'groupId': 'OG006'}, {'value': '1105.999', 'spread': '18.47', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG007'], 'paramType': 'Least Square Means Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '204.8', 'ciLowerLimit': '161.9', 'ciUpperLimit': '259.0', 'estimateComment': 'Analysis was the estimate of the ratio fasted versus fed.', 'groupDescription': 'Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Analyses were based on a pre-defined non-inferiority margin'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.'}, {'type': 'SECONDARY', 'title': 'PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 300 mg LY', 'description': '300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '445.858', 'spread': '32.78', 'groupId': 'OG000'}, {'value': '882.125', 'spread': '32.81', 'groupId': 'OG001'}, {'value': '3687.167', 'spread': '34.83', 'groupId': 'OG002'}, {'value': '3209.396', 'spread': '37.31', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG001', 'title': 'Part A: 3 mg of LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 100 mg of LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 30 mg LY Fed', 'description': '30 mg of LY was taken orally in one of four periods.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean/Coefficient Variation (CV) was not calculated due to n=1. Minimum and maximum values = 1607.0, 1607.0.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean/CV was not calculated due to small sample size n=3. Minimum and maximum values = 2632.0, 3047.0', 'groupId': 'OG001'}, {'value': '7726.17', 'spread': '45.23', 'groupId': 'OG002'}, {'value': '17018.43', 'spread': '62.60', 'groupId': 'OG003'}, {'value': '55406.24', 'spread': '41.35', 'groupId': 'OG004'}, {'value': '66185.70', 'spread': '71.44', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean/CV was not calculated due to n=2. Minimum and maximum values = 63062.0, 83978.0.', 'groupId': 'OG006'}, {'value': '28415.22', 'spread': '56.67', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG007'], 'paramType': 'Least Squares Mean Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '193.3', 'ciLowerLimit': '144.7', 'ciUpperLimit': '258.2', 'groupDescription': 'Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Analyses were based on a pre-defined non-inferiority margin'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'PK is the area under the serum concentration time curve from zero to Infinity (AUC\\[0-∞\\]) of LY3202328 in Part A after a single dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.'}, {'type': 'SECONDARY', 'title': 'PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken 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'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG001', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY or placebo was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 30 mg LY Fed', 'description': '30 mg of LY (fed) was taken orally in one of four periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '3.52', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.2'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '4.1'}, {'value': '6.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '8.0'}, {'value': '4.02', 'groupId': 'OG005', 'lowerLimit': '3.0', 'upperLimit': '8.0'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '24.0'}, {'value': '5.00', 'groupId': 'OG007', 'lowerLimit': '4.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'PK is the time to maximum concentration (Tmax) of LY3202328 in Part A', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A.'}, {'type': 'SECONDARY', 'title': 'PK: Steady State Tmax of LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 300 mg LY', 'description': '300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.20', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.04', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK is the Tmax of LY3202328 at steady state in Part B.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'Participants were randomly assigned to placebo instead of LY in one of the first three periods.'}, {'id': 'OG001', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods..'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.1155', 'groupId': 'OG000'}, {'value': '-0.030', 'spread': '0.0842', 'groupId': 'OG001'}, {'value': '-0.043', 'spread': '0.0454', 'groupId': 'OG002'}, {'value': '-0.047', 'spread': '0.0740', 'groupId': 'OG003'}, {'value': '-0.026', 'spread': '0.0433', 'groupId': 'OG004'}, {'value': '0.052', 'spread': '0.1099', 'groupId': 'OG005'}, {'value': '-0.004', 'spread': '0.0684', 'groupId': 'OG006'}, {'value': '0.010', 'spread': '0.0232', 'groupId': 'OG007'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.1560', 'groupId': 'OG000'}, {'value': '-0.039', 'spread': '0.0217', 'groupId': 'OG001'}, {'value': '0.009', 'spread': '0.1387', 'groupId': 'OG002'}, {'value': '-0.043', 'spread': '0.0950', 'groupId': 'OG003'}, {'value': '-0.026', 'spread': '0.1010', 'groupId': 'OG004'}, {'value': '0.019', 'spread': '0.0978', 'groupId': 'OG005'}, {'value': '-0.009', 'spread': '0.1551', 'groupId': 'OG006'}, {'value': '-0.052', 'spread': '0.0755', 'groupId': 'OG007'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '-0.074', 'spread': '0.1258', 'groupId': 'OG000'}, {'value': '-0.073', 'spread': '0.1241', 'groupId': 'OG001'}, {'value': '-0.086', 'spread': '0.0892', 'groupId': 'OG002'}, {'value': '-0.134', 'spread': '0.0553', 'groupId': 'OG003'}, {'value': '-0.030', 'spread': '0.1304', 'groupId': 'OG004'}, {'value': '-0.091', 'spread': '0.1206', 'groupId': 'OG005'}, {'value': '-0.082', 'spread': '0.1487', 'groupId': 'OG006'}, {'value': '-0.005', 'spread': '0.1411', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.', 'unitOfMeasure': 'millimole/Liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable fasting HDL-c data in Part A.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'A multiple ascending dose of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG004', 'title': 'Part B: 300 mg LY', 'description': '300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.1169', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.1165', 'groupId': 'OG001'}, {'value': '-0.101', 'spread': '0.0812', 'groupId': 'OG002'}, {'value': '-0.107', 'spread': '0.1894', 'groupId': 'OG003'}, {'value': '-0.101', 'spread': '0.0621', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline in Fasting Total Triglycerides Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'Participants were randomly assigned to placebo instead of LY in one of the first three periods.'}, {'id': 'OG001', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '-0.276', 'spread': '0.2043', 'groupId': 'OG000'}, {'value': '-0.397', 'spread': '0.2877', 'groupId': 'OG001'}, {'value': '-0.190', 'spread': '0.1491', 'groupId': 'OG002'}, {'value': '-0.386', 'spread': '0.2766', 'groupId': 'OG003'}, {'value': '-0.311', 'spread': '0.2831', 'groupId': 'OG004'}, {'value': '-0.523', 'spread': '0.5801', 'groupId': 'OG005'}, {'value': '-0.064', 'spread': '0.1455', 'groupId': 'OG006'}, {'value': '-0.302', 'spread': '0.2318', 'groupId': 'OG007'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '-0.320', 'spread': '0.3162', 'groupId': 'OG000'}, {'value': '-0.269', 'spread': '0.2260', 'groupId': 'OG001'}, {'value': '-0.115', 'spread': '0.2643', 'groupId': 'OG002'}, {'value': '-0.260', 'spread': '0.3382', 'groupId': 'OG003'}, {'value': '-0.418', 'spread': '0.3290', 'groupId': 'OG004'}, {'value': '-0.766', 'spread': '0.5870', 'groupId': 'OG005'}, {'value': '-0.226', 'spread': '0.3646', 'groupId': 'OG006'}, {'value': '-0.198', 'spread': '0.1345', 'groupId': 'OG007'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '-0.239', 'spread': '0.3227', 'groupId': 'OG000'}, {'value': '-0.209', 'spread': '0.6817', 'groupId': 'OG001'}, {'value': '-0.132', 'spread': '0.2349', 'groupId': 'OG002'}, {'value': '0.013', 'spread': '0.7179', 'groupId': 'OG003'}, {'value': '-0.331', 'spread': '0.4343', 'groupId': 'OG004'}, {'value': '-0.455', 'spread': '0.5144', 'groupId': 'OG005'}, {'value': '-0.326', 'spread': '0.3549', 'groupId': 'OG006'}, {'value': '0.158', 'spread': '0.6773', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting total triglycerides in Part A.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable fasting triglyceride data in Part A.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'A multiple ascending dose of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG004', 'title': 'Part B: 300 mg LY', 'description': '300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.205', 'spread': '0.6757', 'groupId': 'OG000'}, {'value': '-0.131', 'spread': '0.2720', 'groupId': 'OG001'}, {'value': '-0.231', 'spread': '0.5383', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.6281', 'groupId': 'OG003'}, {'value': '-0.480', 'spread': '0.5235', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD 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orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods.'}, {'id': 'OG004', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '0.085', 'spread': '0.3075', 'groupId': 'OG000'}, {'value': '-0.186', 'spread': '0.2699', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '0.2850', 'groupId': 'OG002'}, {'value': '-0.203', 'spread': '0.2157', 'groupId': 'OG003'}, {'value': '0.073', 'spread': '0.1863', 'groupId': 'OG004'}, {'value': '0.285', 'spread': '0.1903', 'groupId': 'OG005'}, {'value': '0.203', 'spread': '0.2421', 'groupId': 'OG006'}, {'value': '0.093', 'spread': '0.1560', 'groupId': 'OG007'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '-0.085', 'spread': '0.4618', 'groupId': 'OG000'}, {'value': '-0.436', 'spread': '0.2608', 'groupId': 'OG001'}, {'value': '-0.030', 'spread': '0.2218', 'groupId': 'OG002'}, {'value': '-0.376', 'spread': '0.2321', 'groupId': 'OG003'}, {'value': '-0.013', 'spread': '0.3981', 'groupId': 'OG004'}, {'value': '0.091', 'spread': '0.3654', 'groupId': 'OG005'}, {'value': '0.134', 'spread': '0.5446', 'groupId': 'OG006'}, {'value': '-0.026', 'spread': '0.4719', 'groupId': 'OG007'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '-0.318', 'spread': '0.4288', 'groupId': 'OG000'}, {'value': '-0.527', 'spread': '0.3262', 'groupId': 'OG001'}, {'value': '-0.207', 'spread': '0.2949', 'groupId': 'OG002'}, {'value': '-0.609', 'spread': '0.2635', 'groupId': 'OG003'}, {'value': '-0.199', 'spread': '0.4732', 'groupId': 'OG004'}, {'value': '-0.317', 'spread': '0.6296', 'groupId': 'OG005'}, {'value': '-0.155', 'spread': '0.4826', 'groupId': 'OG006'}, {'value': '-0.041', 'spread': '0.6020', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 28, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting total cholesterol in Part A.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable fasting total cholesterol data in Part A.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG004', 'title': 'Part B: 300 mg LY', 'description': '300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.206', 'spread': '0.3615', 'groupId': 'OG000'}, {'value': '0.118', 'spread': '0.3840', 'groupId': 'OG001'}, {'value': '0.183', 'spread': '0.4681', 'groupId': 'OG002'}, {'value': '0.174', 'spread': '0.4963', 'groupId': 'OG003'}, {'value': '-0.190', 'spread': '0.4425', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'Participants were randomly assigned to placebo instead of LY in one of the first three periods.'}, {'id': 'OG001', 'title': 'Part A: 1 mg LY', 'description': '1 mg of LY was taken orally in one of four periods.'}, {'id': 'OG002', 'title': 'Part A: 3 mg LY', 'description': '3 mg of LY was taken orally in one of four periods.'}, {'id': 'OG003', 'title': 'Part A: 10 mg LY', 'description': '10 mg of LY was taken orally in one of four periods..'}, {'id': 'OG004', 'title': 'Part A: 30 mg LY', 'description': '30 mg of LY was taken orally in one of four periods.'}, {'id': 'OG005', 'title': 'Part A: 100 mg LY', 'description': '100 mg of LY was taken orally in one of four periods.'}, {'id': 'OG006', 'title': 'Part A: 300 mg LY', 'description': '300 mg of LY was taken orally in one of four periods.'}, {'id': 'OG007', 'title': 'Part A: 600 mg LY', 'description': '600 mg of LY was taken orally in one of four periods.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '0.231', 'spread': '0.2513', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.2205', 'groupId': 'OG001'}, {'value': '0.117', 'spread': '0.2400', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.2328', 'groupId': 'OG003'}, {'value': '0.241', 'spread': '0.1594', 'groupId': 'OG004'}, {'value': '0.471', 'spread': '0.3418', 'groupId': 'OG005'}, {'value': '0.236', 'spread': '0.2429', 'groupId': 'OG006'}, {'value': '0.163', 'spread': '0.1608', 'groupId': 'OG007'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '0.111', 'spread': '0.4026', 'groupId': 'OG000'}, {'value': '-0.275', 'spread': '0.3004', 'groupId': 'OG001'}, {'value': '0.013', 'spread': '0.2093', 'groupId': 'OG002'}, {'value': '-0.214', 'spread': '0.2378', 'groupId': 'OG003'}, {'value': '0.203', 'spread': '0.3400', 'groupId': 'OG004'}, {'value': '0.419', 'spread': '0.3293', 'groupId': 'OG005'}, {'value': '0.245', 'spread': '0.3457', 'groupId': 'OG006'}, {'value': '-0.001', 'spread': '0.3891', 'groupId': 'OG007'}]}]}, {'title': '96 Hours', 'categories': [{'measurements': [{'value': '-0.109', 'spread': '0.4147', 'groupId': 'OG000'}, {'value': '-0.358', 'spread': '0.4170', 'groupId': 'OG001'}, {'value': '-0.061', 'spread': '0.1747', 'groupId': 'OG002'}, {'value': '-0.481', 'spread': '0.3681', 'groupId': 'OG003'}, {'value': '-0.018', 'spread': '0.3048', 'groupId': 'OG004'}, {'value': '-0.020', 'spread': '0.6327', 'groupId': 'OG005'}, {'value': '0.075', 'spread': '0.2565', 'groupId': 'OG006'}, {'value': '0.038', 'spread': '0.6305', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable LDL-c data in Part A.'}, {'type': 'SECONDARY', 'title': 'PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG001', 'title': 'Part B: 5 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG002', 'title': 'Part B: 20 mg LY', 'description': '20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG003', 'title': 'Part B: 100 mg LY', 'description': '100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'OG004', 'title': 'Part B: 300 mg LY', 'description': '5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.103', 'spread': '0.4114', 'groupId': 'OG000'}, {'value': '0.184', 'spread': '0.3419', 'groupId': 'OG001'}, {'value': '0.388', 'spread': '0.4876', 'groupId': 'OG002'}, {'value': '0.227', 'spread': '0.4494', 'groupId': 'OG003'}, {'value': '0.131', 'spread': '0.4225', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin With LY (Test)', 'description': 'A single simvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).'}, {'id': 'OG001', 'title': 'Simvastatin Alone (Reference)', 'description': 'A single simvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '2.906', 'spread': '18.72', 'groupId': 'OG000'}, {'value': '2.061', 'spread': '71.24', 'groupId': 'OG001'}]}]}, {'title': '5 mg LY', 'categories': [{'measurements': [{'value': '2.388', 'spread': '58.17', 'groupId': 'OG000'}, {'value': '3.374', 'spread': '52.99', 'groupId': 'OG001'}]}]}, {'title': '20 mg LY', 'categories': [{'measurements': [{'value': '3.576', 'spread': '19.35', 'groupId': 'OG000'}, {'value': '3.274', 'spread': '26.87', 'groupId': 'OG001'}]}]}, {'title': '100 mg LY', 'categories': [{'measurements': [{'value': '4.634', 'spread': '55.59', 'groupId': 'OG000'}, {'value': '4.303', 'spread': '25.45', 'groupId': 'OG001'}]}]}, {'title': '300 mg LY', 'categories': [{'measurements': [{'value': '4.221', 'spread': '58.78', 'groupId': 'OG000'}, {'value': '1.979', 'spread': '55.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '141.0', 'ciLowerLimit': '67.9', 'ciUpperLimit': '293.0', 'groupDescription': 'Part B Placebo', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '70.8', 'ciLowerLimit': '31.9', 'ciUpperLimit': '157.1', 'groupDescription': 'Part B 5 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.2', 'ciLowerLimit': '99.8', 'ciUpperLimit': '119.5', 'groupDescription': 'Part B 20 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.7', 'ciLowerLimit': '68.1', 'ciUpperLimit': '170.4', 'groupDescription': 'Part B 100 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '213.3', 'ciLowerLimit': '200.3', 'ciUpperLimit': '227.1', 'groupDescription': 'Part B 300 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.4', 'ciLowerLimit': '91.2', 'ciUpperLimit': '146.2', 'groupDescription': 'Part B Overall', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin With LY (Test)', 'description': 'A single simvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).'}, {'id': 'OG001', 'title': 'Simvastatin Alone (Reference)', 'description': 'A single simvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '9.648', 'spread': '38.82', 'groupId': 'OG000'}, {'value': '6.250', 'spread': '61.54', 'groupId': 'OG001'}]}]}, {'title': '5 mg LY', 'categories': [{'measurements': [{'value': '6.668', 'spread': '42.96', 'groupId': 'OG000'}, {'value': '9.287', 'spread': '57.54', 'groupId': 'OG001'}]}]}, {'title': '20 mg LY', 'categories': [{'measurements': [{'value': '9.697', 'spread': '26.81', 'groupId': 'OG000'}, {'value': '7.960', 'spread': '32.21', 'groupId': 'OG001'}]}]}, {'title': '100 mg LY', 'categories': [{'measurements': [{'value': '14.269', 'spread': '53.78', 'groupId': 'OG000'}, {'value': '10.434', 'spread': '26.20', 'groupId': 'OG001'}]}]}, {'title': '300 mg LY', 'categories': [{'measurements': [{'value': '11.908', 'spread': '60.19', 'groupId': 'OG000'}, {'value': '8.951', 'spread': '61.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '155', 'ciLowerLimit': '87.6', 'ciUpperLimit': '274.2', 'groupDescription': 'Part B Placebo', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '71.5', 'ciLowerLimit': '40.7', 'ciUpperLimit': '125.3', 'groupDescription': 'Part B 5 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratios (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122.4', 'ciLowerLimit': '90.7', 'ciUpperLimit': '165.1', 'groupDescription': 'Part B 20 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '136.6', 'ciLowerLimit': '89.8', 'ciUpperLimit': '207.7', 'groupDescription': 'Part B 100 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '132.6', 'ciLowerLimit': '90.5', 'ciUpperLimit': '194.4', 'groupDescription': 'Part B 300 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '112.2', 'ciLowerLimit': '93.2', 'ciUpperLimit': '135.1', 'groupDescription': 'Part B Overall', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Area Under Concentration Curve From Zero to Time (AUC \\[0-t\\]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin With LY (Test)', 'description': 'A single atorvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).'}, {'id': 'OG001', 'title': 'Atorvastatin Alone (Reference)', 'description': 'A single atorvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '3.479', 'spread': '20.58', 'groupId': 'OG000'}, {'value': '3.575', 'spread': '30.44', 'groupId': 'OG001'}]}]}, {'title': '5 mg LY', 'categories': [{'measurements': [{'value': '2.840', 'spread': '27.96', 'groupId': 'OG000'}, {'value': '3.621', 'spread': '82.05', 'groupId': 'OG001'}]}]}, {'title': '20 mg LY', 'categories': [{'measurements': [{'value': '1.238', 'spread': '38.05', 'groupId': 'OG000'}, {'value': '1.286', 'spread': '45.27', 'groupId': 'OG001'}]}]}, {'title': '100 mg LY', 'categories': [{'measurements': [{'value': '2.511', 'spread': '32.17', 'groupId': 'OG000'}, {'value': '3.105', 'spread': '51.95', 'groupId': 'OG001'}]}]}, {'title': '300 mg LY', 'categories': [{'measurements': [{'value': '1.489', 'spread': '42.11', 'groupId': 'OG000'}, {'value': '1.376', 'spread': '59.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.3', 'ciLowerLimit': '80.4', 'ciUpperLimit': '117.8', 'groupDescription': 'Part B Placebo', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '57.5', 'ciLowerLimit': '31.3', 'ciUpperLimit': '106.0', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.2', 'ciLowerLimit': '66.8', 'ciUpperLimit': '138.7', 'groupDescription': 'Part B 20 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '80.9', 'ciLowerLimit': '45.8', 'ciUpperLimit': '142.7', 'groupDescription': 'Part B 100 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.2', 'ciLowerLimit': '40.2', 'ciUpperLimit': '291.2', 'groupDescription': 'Part B 300 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.9', 'ciLowerLimit': '67.4', 'ciUpperLimit': '114.7', 'groupDescription': 'Part B Overall', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.'}, {'type': 'SECONDARY', 'title': 'PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin With LY (Test)', 'description': 'A single atorvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).'}, {'id': 'OG001', 'title': 'Atorvastatin Alone (Reference)', 'description': 'A single atorvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '15.874', 'spread': '32.81', 'groupId': 'OG000'}, {'value': '16.518', 'spread': '33.88', 'groupId': 'OG001'}]}]}, {'title': '5 mg LY', 'categories': [{'measurements': [{'value': '17.311', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '14.913', 'spread': '48.97', 'groupId': 'OG001'}]}]}, {'title': '20 mg LY', 'categories': [{'measurements': [{'value': '7.921', 'spread': '57.94', 'groupId': 'OG000'}, {'value': '7.952', 'spread': '63.04', 'groupId': 'OG001'}]}]}, {'title': '100 mg LY', 'categories': [{'measurements': [{'value': '11.983', 'spread': '38.63', 'groupId': 'OG000'}, {'value': '13.207', 'spread': '61.25', 'groupId': 'OG001'}]}]}, {'title': '300 mg LY', 'categories': [{'measurements': [{'value': '7.748', 'spread': '50.04', 'groupId': 'OG000'}, {'value': '9.111', 'spread': '36.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.0', 'ciLowerLimit': '90.2', 'ciUpperLimit': '102.1', 'groupDescription': 'Part B Placebo', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.7', 'ciLowerLimit': '59.8', 'ciUpperLimit': '137.6', 'groupDescription': 'Part B 5 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.9', 'ciLowerLimit': '75.9', 'ciUpperLimit': '131.5', 'groupDescription': 'Part B 20 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Square Means Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.0', 'ciLowerLimit': '67.5', 'ciUpperLimit': '122.7', 'groupDescription': 'Part B 100 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.0', 'ciLowerLimit': '42.0', 'ciUpperLimit': '180.5', 'groupDescription': 'Part B 300 mg LY', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis testing'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.5', 'ciLowerLimit': '81.8', 'ciUpperLimit': '106.9', 'groupDescription': 'Part B Overall', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio estimate without hypothesis'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data in Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Cohort 1(C1), Sequence 1', 'description': '1 milligram (mg) of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.\n\nC1, Sequence 1: (1 mg LY, 10 mg LY, Placebo, 600 mg LY)'}, {'id': 'FG001', 'title': 'Part A: C1, Sequence 2', 'description': '1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.\n\nC1, Sequence 2: (1 mg LY, Placebo, 100 mg LY, 600 mg LY)'}, {'id': 'FG002', 'title': 'Part A: C1, Sequence 3', 'description': 'Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention.\n\nC1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)'}, {'id': 'FG003', 'title': 'Part A: Cohort 2 (C2), Sequence 1', 'description': '3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.\n\nC2, Sequence 1: (3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed)'}, {'id': 'FG004', 'title': 'Part A: C2, Sequence 2', 'description': '3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention.\n\nC2, Sequence 2: (3 mg LY, Placebo, 300 mg LY, Placebo)'}, {'id': 'FG005', 'title': 'Part A: C2, Sequence 3', 'description': 'Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.\n\nC2, Sequence 3: (Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed)'}, {'id': 'FG006', 'title': 'Part B: C3 (Simvastatin [SS]/Atorvastatin[AS] + 5 mg LY)', 'description': '5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'FG007', 'title': 'Part B: C4 (SS/AS + 20 mg LY)', 'description': '20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'FG008', 'title': 'Part B: C5 (SS/AS + 100 mg LY)', 'description': '100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'FG009', 'title': 'Part B: C6 (SS/AS + 300 mg LY)', 'description': '300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'FG010', 'title': 'Part B: C3-C6 (SS/AS + Placebo)', 'description': 'Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}], 'periods': [{'title': 'Part A First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part A Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part A Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Positive Urine Drug Screen (UDS)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part A Fourth Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'An additional participant replaced a discontinued participant.', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'comment': 'An additional participant replaced a discontinued participant.', 'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Positive Urinary Drug Screen (UDS)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part B (Overall)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Part A participants completed period 4 and were not in part B.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Part B participants randomized to receive 5 mg of LY3202328 + atorvastatin/simvastatin.', 'groupId': 'FG006', 'numSubjects': '8'}, {'comment': 'Part B participants randomized to receive 20 mg of LY3202328 + atorvastatin/simvastatin.', 'groupId': 'FG007', 'numSubjects': '8'}, {'comment': 'Part B participants randomized to receive 100 mg of LY3202328 + atorvastatin/simvastatin.', 'groupId': 'FG008', 'numSubjects': '8'}, {'comment': 'Part B participants randomized to receive 300 mg of LY3202328 + atorvastatin/simvastatin.', 'groupId': 'FG009', 'numSubjects': '8'}, {'comment': 'Part B participants randomized to receive placebo instead of LY3202328 + atorvastatin/simvastatin.', 'groupId': 'FG010', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Part A participants were divided into 2 cohorts. Within each cohort, participants were randomized to a treatment sequence (4 periods; up to 3 LY dose levels and at least one placebo). A 2-week washout occurred between each period. Part B participants were divided into 4 cohorts. Within each cohort, participants were randomized to LY or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '60', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, C1, Sequence 1', 'description': '1 mg of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.\n\nC1, Sequence 1:\n\n(1 mg LY, 10 mg LY, Placebo, 600 mg LY)'}, {'id': 'BG001', 'title': 'Part A, C1, Sequence 2', 'description': '1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.\n\nC1, Sequence 2:\n\n(1 mg LY, Placebo, 100 mg LY, 600 mg LY)'}, {'id': 'BG002', 'title': 'Part A, C1, Sequence 3', 'description': 'Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention.\n\nC1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)'}, {'id': 'BG003', 'title': 'Part A, C2, Sequence 1', 'description': '3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention\n\nC2, Sequence 1:\n\n3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed'}, {'id': 'BG004', 'title': 'Part A, C2, Sequence 2', 'description': '3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention.\n\nC2, Sequence 2:\n\n3 mg LY, Placebo, 300 mg LY, Placebo'}, {'id': 'BG005', 'title': 'Part A, C2, Sequence 3', 'description': 'Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.\n\nC2, Sequence 3:\n\nPlacebo, 30 mg LY, 300 mg LY, 30 mg LY Fed'}, {'id': 'BG006', 'title': 'Part B: SS/AS/Placebo', 'description': 'Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'BG007', 'title': 'Part B: SS/AS/5 mg LY', 'description': '5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'BG008', 'title': 'Part B: SS/AS/20 mg LY', 'description': '20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'BG009', 'title': 'Part B: SS/AS/100 mg LY', 'description': '100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'BG010', 'title': 'Part B: SS/AS/300 mg LY', 'description': '300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '8.02', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '12.12', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '4.04', 'groupId': 'BG002'}, {'value': '34.0', 'spread': '13.53', 'groupId': 'BG003'}, {'value': '38.3', 'spread': '22.50', 'groupId': 'BG004'}, {'value': '54.7', 'spread': '17.21', 'groupId': 'BG005'}, {'value': '54.0', 'spread': '9.12', 'groupId': 'BG006'}, {'value': '50.5', 'spread': '12.76', 'groupId': 'BG007'}, {'value': '46.8', 'spread': '13.13', 'groupId': 'BG008'}, {'value': '55.0', 'spread': '10.18', 'groupId': 'BG009'}, {'value': '36.9', 'spread': '10.80', 'groupId': 'BG010'}, {'value': '48.7', 'spread': '13.22', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '39', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '45', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '47', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '60', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug in Part A and Part B.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-28', 'size': 873742, 'label': 'Study Protocol: GSEA Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-06T15:38', 'hasProtocol': True}, {'date': '2016-06-22', 'size': 1247413, 'label': 'Study Protocol: GSEA Protocol (a)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-06T15:41', 'hasProtocol': True}, {'date': '2017-01-31', 'size': 457249, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-06T15:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part A is a crossover. Part B is a parallel assignment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2016-03-16', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B', 'timeFrame': 'Baseline, Up to 42 Days', 'description': 'Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.'}, {'measure': 'PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B', 'timeFrame': 'Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.'}, {'measure': 'PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'PK is the area under the serum concentration time curve from zero to Infinity (AUC\\[0-∞\\]) of LY3202328 in Part A after a single dose.'}, {'measure': 'PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B', 'timeFrame': 'Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.'}, {'measure': 'PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose', 'description': 'PK is the time to maximum concentration (Tmax) of LY3202328 in Part A'}, {'measure': 'PK: Steady State Tmax of LY3202328 (LY) in Part B', 'timeFrame': 'Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK is the Tmax of LY3202328 at steady state in Part B.'}, {'measure': 'Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.'}, {'measure': 'PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.'}, {'measure': 'PD: Change From Baseline in Fasting Total Triglycerides Part A', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting total triglycerides in Part A.'}, {'measure': 'PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.'}, {'measure': 'PD: Change From Baseline to in Fasting Total Cholesterol in Part A', 'timeFrame': 'Predose, 24, 28, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting total cholesterol in Part A.'}, {'measure': 'PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.'}, {'measure': 'PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A', 'timeFrame': 'Predose, 24, 48, 96 Hours Postdose', 'description': 'PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.'}, {'measure': 'PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B', 'timeFrame': 'Predose, Days 7, 14, 21, and 28 Postdose', 'description': 'PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.'}, {'measure': 'PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.'}, {'measure': 'PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Area Under Concentration Curve From Zero to Time (AUC \\[0-t\\]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.'}, {'measure': 'PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.'}, {'measure': 'PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B', 'timeFrame': 'Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose', 'description': 'PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/dyslipidemia/GSEA#?postal=', 'label': 'A Study of LY3202328 in Overweight Healthy Participants and in Participants With Dyslipidemia'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this two-part study is to evaluate the safety and tolerability of the study drug known as LY3202328 in healthy overweight participants in Part A, and those with dyslipidemia (abnormal blood fats) in Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be healthy, as determined by medical history and physical examination\n* Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product\n* Female participants must be between 40 and 70 years old, and either postmenopausal or with a hysterectomy, and not pregnant and not lactating\n* Be on a stable diet and exercise regimen for greater than (\\>) 3 months prior\n* Have a body mass index (BMI) of 25.0 to 35.0 (Part A) or 27.0 to 40.0 (Part B) kilograms per meter squared\n* Have fasting triglycerides (TG) between 150 and 499 milligrams per deciliter (mg/dL) (Part B only)\n* Have a fasting low-density lipoprotein cholesterol (LDL-c) between 100 and 200 mg/dL (Part B only)\n* Have estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute/1.73 meter squared with no proteinuria\n* Be normotensive defined as supine systolic blood pressure (BP) less than or equal to (≤) 150 millimeters of mercury (mm Hg) and diastolic BP ≤ 100 mm Hg, without the use of any antihypertensive\n\nExclusion Criteria:\n\n* Are taking a statin, any proprotein convertase subtilisin/kexin type 9 (PCSK9) medications, or have started taking other TG lowering agents (for example, niacin, fish oils)\n* Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research, or have participated in a clinical trial involving an investigational product or non-approved use of a drug within the last 30 days or within 5 half-lives\n* Have an abnormal electrocardiogram or corrected QT or are on antihypertensive treatment\n* Have any current or prior history of significant cardiovascular disease\n* Show evidence of hepatitis C virus (HCV), Hepatitis B or other chronic liver disease\n* Have an alcohol intake that exceeds 7 units per week with no more than 3 units per day, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits), or are a regular user of known drugs of abuse\n* Have a history of untreated endocrine illness such as diabetes mellitus\n* Have been on medications or supplements for weight loss within 3 months\n* Have a history of active neuropsychiatric disease or on pharmacological therapy for such conditions (Part B, only)\n* Show evidence of human immunodeficiency virus (HIV) infection\n* Have been on medications that are known to inhibit cytochrome P450, family 3, subfamily A (CYP3A) or P-glycoprotein (P-gp), or regularly consume grapefruit\n* Have donated blood of more than 500 mL within the last month\n* Smoke \\>10 cigarettes per day or are unwilling to follow smoking rules'}, 'identificationModule': {'nctId': 'NCT02714569', 'briefTitle': 'A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328', 'orgStudyIdInfo': {'id': '16417'}, 'secondaryIdInfos': [{'id': 'I8Q-MC-GSEA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: LY3202328 (LY)', 'description': 'Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods.', 'interventionNames': ['Drug: LY3202328']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY3202328 (LY)', 'description': 'A multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.', 'interventionNames': ['Drug: LY3202328', 'Drug: Atorvastatin', 'Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.', 'interventionNames': ['Drug: Placebo', 'Drug: Atorvastatin', 'Drug: Simvastatin']}], 'interventions': [{'name': 'LY3202328', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part A: LY3202328 (LY)', 'Part B: LY3202328 (LY)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part B: LY3202328 (LY)', 'Part B: Placebo']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part B: LY3202328 (LY)', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '06219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}