Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 3:46 PM
Study NCT ID:
NCT05445232
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D002110', 'term': 'Caffeine'}], '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'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04-01', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'PK: AUC\\[0-∞\\] of Midazolam'}, {'measure': 'PK: Maximum Observed Concentration (Cmax) of Midazolam', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'PK: Cmax of Midazolam'}, {'measure': 'PK: AUC[0-∞] of Warfarin', 'timeFrame': 'Predose up to 96 hours postdose', 'description': 'PK: AUC\\[0-∞\\] of Warfarin'}, {'measure': 'PK: Cmax of Warfarin', 'timeFrame': 'Predose up to 96 hours postdose', 'description': 'PK: Cmax of Warfarin'}, {'measure': 'PK: AUC[0-∞] of Caffeine', 'timeFrame': 'Predose up to 48 hours postdose', 'description': 'PK: AUC\\[0-∞\\] of Caffeine'}, {'measure': 'PK: Cmax of Caffeine', 'timeFrame': 'Predose up to 48 hours postdose', 'description': 'PK: Cmax of Caffeine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Drug Interaction', 'Cocktail', 'Pharmacokinetic'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)\n* Male and female participants of childbearing potential who agree to use contraceptive methods\n\nExclusion Criteria:\n\n* Have a history of diabetes or current diagnosis of diabetes\n* History or presence of a of significant bleeding disorder\n* Participants with significant comorbidity\n* Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index'}, 'identificationModule': {'nctId': 'NCT05445232', 'briefTitle': 'A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes', 'orgStudyIdInfo': {'id': '18476'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3437943 + Drug Cocktail', 'description': 'Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.\n\nAt weeks 8, 12, \\& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.', 'interventionNames': ['Drug: LY3437943', 'Drug: Midazolam', 'Drug: Warfarin', 'Drug: Caffeine']}], 'interventions': [{'name': 'LY3437943', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3437943 + Drug Cocktail']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3437943 + Drug Cocktail']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3437943 + Drug Cocktail']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3437943 + Drug Cocktail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}}}}