Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT05611957
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09-15', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', '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 31 days postdose', 'description': 'PK: AUC0-∞ of LY3437943'}, {'measure': 'PK: Maximum observed concentration (Cmax) of LY3437943', 'timeFrame': 'Predose up to 31 days postdose', 'description': 'PK: Cmax of LY3437943'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 5 weeks, excluding screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNormal Participants:\n\n* Healthy male and female participants as determined by physical examination\n* Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).\n* Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)\n* Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.\n\nParticipants with Renal Impairment:\n\n* Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator\n* Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5%\n* Are males or females with severe renal impairment as determined by a stable eGFR \\<30 mL/min, not requiring hemodialysis OR\n* Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)\n\nExclusion Criteria:\n\n* Have known allergies to LY3437943 or related compounds\n* Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed\n* Have any abnormality in the 12-lead electrocardiogram (ECG)\n* Are women with a positive pregnancy test or women who are lactating'}, 'identificationModule': {'nctId': 'NCT05611957', 'briefTitle': 'A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants', 'orgStudyIdInfo': {'id': '18529'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Control)', 'description': 'LY3437943 administered subcutaneous (SC) to participants with normal renal function', 'interventionNames': ['Drug: LY3437943']}, {'type': 'EXPERIMENTAL', 'label': 'LY3437943 (Severe Renal Impairment)', 'description': 'LY3437943 administered SC to participants with severe renal impairment', 'interventionNames': ['Drug: LY3437943']}, {'type': 'EXPERIMENTAL', 'label': 'LY3437943 (End-Stage Renal Disease)', 'description': 'LY3437943 administered SC to participants with end-stage renal disease', 'interventionNames': ['Drug: LY3437943']}], 'interventions': [{'name': 'LY3437943', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3437943 (Control)', 'LY3437943 (End-Stage Renal Disease)', 'LY3437943 (Severe Renal Impairment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Nucleus Networks', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], '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'}}}}