Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-03 @ 3:10 PM
Study NCT ID:
NCT02906618
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of LY3039478 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654634', 'term': 'crenigacestat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV', 'description': 'Simultaneous administration of a single oral dose of 75 mg of LY3039478 and a 45-minute IV administration of 350 μg 13C 15N 2H-LY3039478 in healthy participants.', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY3039478 - Oral', 'description': 'On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.'}, {'id': 'OG001', 'title': '13C 15N 2H-LY3039478 - IV', 'description': 'On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '1920', 'spread': '23', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\\[0-tlast\\]) of LY3039478 and 13C 15N 2H-LY3039478.', 'unitOfMeasure': 'nangogram*hour/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY3039478 - Oral', 'description': 'On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.'}, {'id': 'OG001', 'title': '13C 15N 2H-LY3039478 - IV', 'description': 'On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '1920', 'spread': '23', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.572', 'ciLowerLimit': '0.532', 'ciUpperLimit': '0.615', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is AUC from zero to infinity (AUC\\[0 - inf\\]) of LY3039478 and 13C 15N 2H-LY3039478.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY3039478 - Oral', 'description': 'On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.'}, {'id': 'OG001', 'title': '13C 15N 2H-LY3039478 - IV', 'description': 'On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '444', 'spread': '23', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.', 'unitOfMeasure': 'nanogram/millilter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY3039478 - Oral', 'description': 'On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.'}, {'id': 'OG001', 'title': '13C 15N 2H-LY3039478 - IV', 'description': 'On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.500', 'groupId': 'OG000', 'lowerLimit': '1.000', 'upperLimit': '3.500'}, {'value': '0.750', 'groupId': 'OG001', 'lowerLimit': '0.750', 'upperLimit': '0.750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY3039478 - Oral', 'description': 'On Day 1 following an overnight fast of at least 10 hours, participants received a single oral dose of 75 mg LY3039478.'}, {'id': 'OG001', 'title': '13C 15N 2H-LY3039478 - IV', 'description': 'On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '4.93', 'upperLimit': '6.88'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '2.84', 'upperLimit': '3.75'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV', 'description': 'Simultaneous administration of a single oral dose of 75 milligram (mg) of LY3039478 and a 45-minute IV administration of 350 microgram (μg) 13C15N2H-LY3039478 in healthy participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'LY3039478 given once, orally and 13C 15N 2H-LY3039478 given once, IV.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '15.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '177.00', 'spread': '7.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.97', 'spread': '10.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.82', 'spread': '2.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram/square meter (kg/m²)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2016-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2016-09-15', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2016-09-15', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-20', 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\\[0-tlast\\]) of LY3039478 and 13C 15N 2H-LY3039478.'}, {'measure': 'PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is AUC from zero to infinity (AUC\\[0 - inf\\]) of LY3039478 and 13C 15N 2H-LY3039478.'}], 'secondaryOutcomes': [{'measure': 'PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.'}, {'measure': 'PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.'}, {'measure': 'PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose', 'description': 'PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:\n\n* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV\n* How long it takes the body to remove the study drug\n* The safety of LY3039478 and any side effects that might be associated with it\n\nParticipation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive\n\nExclusion Criteria:\n\n\\- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product\n\n• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT02906618', 'briefTitle': 'Study of LY3039478 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method', 'orgStudyIdInfo': {'id': '16344'}, 'secondaryIdInfos': [{'id': 'I6F-MC-JJCG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-001073-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3039478 - Oral', 'description': 'LY3039478 given once, orally', 'interventionNames': ['Drug: LY3039478']}, {'type': 'EXPERIMENTAL', 'label': '13C 15N 2H-LY3039478 - IV', 'description': '13C 15N 2H-LY3039478 given once, IV', 'interventionNames': ['Drug: 13C 15N 2H-LY3039478 IV']}], 'interventions': [{'name': 'LY3039478', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3039478 - Oral']}, {'name': '13C 15N 2H-LY3039478 IV', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['13C 15N 2H-LY3039478 - IV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}