Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT04559568
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2020-09-21
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY3522348 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'Part A: Baseline up to Day 14; Part B: Baseline up to Day 28', 'description': 'All enrolled participants, irrespective of the completion of all protocol requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Placebo', 'description': 'A single dose of Placebo administered orally on Day 1.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: Placebo', 'description': 'Placebo administered orally once daily on Days 1-14.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: Placebo + Midazolam', 'description': 'Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Medical device site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'A single dose of Placebo administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG004', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG005', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG006', 'title': 'Part B: Placebo', 'description': 'Placebo administered orally once daily on Days 1-14.'}, {'id': 'OG007', 'title': 'Part B: Placebo + Midazolam', 'description': 'Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}, {'id': 'OG008', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG009', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG010', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part A: Baseline up to Day 14; Part B: Baseline up to Day 28', 'description': 'An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants, irrespective of the completion of all protocol requirements.'}, {'type': 'SECONDARY', 'title': 'Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG004', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.330', 'spread': '25', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '30', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '20', 'groupId': 'OG002'}, {'value': '9.45', 'spread': '37', 'groupId': 'OG003'}, {'value': '25.3', 'spread': '24', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)', 'description': 'PK: AUC(0-tlast) of LY3522348', 'unitOfMeasure': 'microgram*hour/milliliter (μg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG001', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG002', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '25', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '18', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '25', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.00', 'spread': '29', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '31', 'groupId': 'OG001'}, {'value': '20.4', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)', 'description': 'PK: AUC(0-tlast) of LY3522348', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.'}, {'id': 'OG004', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00964', 'spread': '17', 'groupId': 'OG000'}, {'value': '0.0399', 'spread': '23', 'groupId': 'OG001'}, {'value': '0.113', 'spread': '23', 'groupId': 'OG002'}, {'value': '0.323', 'spread': '39', 'groupId': 'OG003'}, {'value': '0.897', 'spread': '18', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)', 'description': 'PK: Cmax of LY3522348', 'unitOfMeasure': 'micrograms/mililiter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG001', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'OG002', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.109', 'spread': '29', 'groupId': 'OG000'}, {'value': '0.330', 'spread': '15', 'groupId': 'OG001'}, {'value': '0.690', 'spread': '13', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.188', 'spread': '25', 'groupId': 'OG000'}, {'value': '0.464', 'spread': '15', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)', 'description': 'PK: Cmax of LY3522348', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Placebo', 'description': 'A single dose of Placebo administered orally on Day 1.'}, {'id': 'FG001', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.'}, {'id': 'FG002', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.'}, {'id': 'FG003', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.'}, {'id': 'FG004', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.'}, {'id': 'FG005', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.'}, {'id': 'FG006', 'title': 'Part B: Placebo', 'description': 'Placebo administered orally once daily on Days 1-14.'}, {'id': 'FG007', 'title': 'Part B: Placebo + Midazolam', 'description': 'Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}, {'id': 'FG008', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'FG009', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'FG010', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'Received At Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '6'}]}, {'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': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', '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'}]}, {'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': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '65', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Placebo', 'description': 'A single dose of Placebo administered orally on Day 1.'}, {'id': 'BG001', 'title': 'Part A: 5 mg LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.'}, {'id': 'BG002', 'title': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.'}, {'id': 'BG003', 'title': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.'}, {'id': 'BG004', 'title': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.'}, {'id': 'BG005', 'title': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.'}, {'id': 'BG006', 'title': 'Part B: Placebo', 'description': 'Placebo administered orally once daily on Days 1-14.'}, {'id': 'BG007', 'title': 'Part B: Placebo + Midazolam', 'description': 'Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}, {'id': 'BG008', 'title': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'BG009', 'title': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.'}, {'id': 'BG010', 'title': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '62'}, {'value': '53.5', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '64'}, {'value': '48.8', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '64'}, {'value': '56.0', 'groupId': 'BG003', 'lowerLimit': '38', 'upperLimit': '65'}, {'value': '57.0', 'groupId': 'BG004', 'lowerLimit': '45', 'upperLimit': '64'}, {'value': '31.0', 'groupId': 'BG005', 'lowerLimit': '27', 'upperLimit': '36'}, {'value': '47.5', 'groupId': 'BG006', 'lowerLimit': '36', 'upperLimit': '62'}, {'value': '57.0', 'groupId': 'BG007', 'lowerLimit': '55', 'upperLimit': '59'}, {'value': '43.0', 'groupId': 'BG008', 'lowerLimit': '28', 'upperLimit': '54'}, {'value': '36.3', 'groupId': 'BG009', 'lowerLimit': '29', 'upperLimit': '39'}, {'value': '45.0', 'groupId': 'BG010', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '47.3', 'groupId': 'BG011', 'lowerLimit': '27', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '26', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '6', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '42', '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': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '26', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '39', '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'}], 'populationDescription': 'All enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-11', 'size': 1287886, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-06T12:23', 'hasProtocol': True}, {'date': '2021-09-03', 'size': 3873540, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-07T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2020-09-21', 'resultsFirstSubmitDate': '2025-10-16', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-16', 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08-17', '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', 'timeFrame': 'Part A: Baseline up to Day 14; Part B: Baseline up to Day 28', 'description': 'An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)', 'description': 'PK: AUC(0-tlast) of LY3522348'}, {'measure': 'Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)', 'description': 'PK: AUC(0-tlast) of LY3522348'}, {'measure': 'Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)', 'description': 'PK: Cmax of LY3522348'}, {'measure': 'Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348', 'timeFrame': 'Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)', 'description': 'PK: Cmax of LY3522348'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40358849', 'type': 'DERIVED', 'citation': 'Fukuda T, Thompson BR, Brouwers B, Qian HR, Wang W, Morse BL, LaBell ES, Durham TB, Konig M, Haupt A, Benson CT, MacKrell J. LY3522348, A New Ketohexokinase Inhibitor: A First-in-Human Study in Healthy Adults. Diabetes Ther. 2025 Jul;16(7):1399-1415. doi: 10.1007/s13300-025-01752-5. Epub 2025 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy as determined through medical evaluation including medical history and physical examination\n* Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)\n* Have had a stable weight for one month prior to screening and enrollment (less than \\[\\<\\]5 percent \\[%\\] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment\n* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator\n\nExclusion Criteria:\n\n* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis\n* Have blood pressure of greater than (\\>)160/90 millimeters of mercury (mmHg) and pulse rate \\<50 or \\>100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator\n* Have a history of fructosuria\n* Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study'}, 'identificationModule': {'nctId': 'NCT04559568', 'briefTitle': 'A Study of LY3522348 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants', 'orgStudyIdInfo': {'id': '17808'}, 'secondaryIdInfos': [{'id': 'J2U-MC-YBAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'A single dose of Placebo administered orally on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: 5 milligrams (mg) LY3522348', 'description': 'A single dose of 5 mg LY3522348 administered orally on Day 1.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: 15 mg LY3522348', 'description': 'A single dose of 15 mg LY3522348 administered orally on Day 1.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: 50 mg LY3522348', 'description': 'A single dose of 50 mg LY3522348 administered orally on Day 1.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: 150 mg LY3522348', 'description': 'A single dose of 150 mg LY3522348 administered orally on Day 1.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: 380 mg LY3522348', 'description': 'A single dose of 380 mg LY3522348 administered orally on Day 1.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Placebo administered orally once daily on Days 1-14.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Placebo + Midazolam', 'description': 'Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15.', 'interventionNames': ['Drug: Placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 50 mg LY3522348', 'description': '50 mg LY3522348 administered orally once daily on Days 1-14.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 120 mg LY3522348', 'description': '120 mg LY3522348 administered orally once daily on Days 1-14.', 'interventionNames': ['Drug: LY3522348']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 290 mg LY3522348 + Midazolam', 'description': '290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.', 'interventionNames': ['Drug: LY3522348', 'Drug: Midazolam']}], 'interventions': [{'name': 'LY3522348', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Part A: 15 mg LY3522348', 'Part A: 150 mg LY3522348', 'Part A: 380 mg LY3522348', 'Part A: 5 milligrams (mg) LY3522348', 'Part A: 50 mg LY3522348', 'Part B: 120 mg LY3522348', 'Part B: 290 mg LY3522348 + Midazolam', 'Part B: 50 mg LY3522348']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo', 'Part B: Placebo + Midazolam']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Part B: 290 mg LY3522348 + Midazolam', 'Part B: Placebo + Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], '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'}}}}