Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-11 @ 11:30 AM
Study NCT ID:
NCT05916560
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943', 'timeFrame': 'Predose up to 30 days postdose', 'description': 'PK: AUC0-∞ of LY3437943'}, {'measure': 'PK: Maximum observed concentration (Cmax) of LY3437943', 'timeFrame': 'Predose up to 30 days postdose', 'description': 'PK: Cmax of LY3437943'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Hepatic Impairment'], 'conditions': ['Healthy', 'Hepatic Insufficiency']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Participants:\n\n* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive\n* Healthy or various degrees of hepatic impairment depending on the study group\n\nExclusion Criteria:\n\nParticipants with hepatic impairment:\n\n* Have or are anticipating an organ transplant within the next 6 months\n* Requires needle evacuation of ascites fluid more than 2 times per month\n* Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure'}, 'identificationModule': {'nctId': 'NCT05916560', 'briefTitle': 'A Study of LY3437943 in Participants With Impaired and Normal Liver Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants', 'orgStudyIdInfo': {'id': '18531'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBT', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Normal Hepatic Function)', 'description': 'LY3437943 administered subcutaneously (SC).', 'interventionNames': ['Drug: LY3437943']}, {'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Severe Hepatic Impairment)', 'description': 'LY3437943 administered SC.', 'interventionNames': ['Drug: LY3437943']}, {'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Moderate Hepatic Impairment)', 'description': 'LY3437943 administered SC.', 'interventionNames': ['Drug: LY3437943']}, {'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Mild Hepatic Impairment)', 'description': 'LY3437943 administered SC.', 'interventionNames': ['Drug: LY3437943']}], 'interventions': [{'name': 'LY3437943', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3437943 (Mild Hepatic Impairment)', 'LY3437943 (Moderate Hepatic Impairment)', 'LY3437943 (Normal Hepatic Function)', 'LY3437943 (Severe Hepatic Impairment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Trials - Chandler', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites- Clinical Research Unit', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33147-4040', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'American Research Corporation at Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], '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'}}}}