{"protocolSection":{"identificationModule":{"nctId":"NCT06370728","orgStudyIdInfo":{"id":"18621"},"secondaryIdInfos":[{"id":"J2A-MC-GZPJ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants","officialTitle":"A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-05-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-23","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-23","type":"ACTUAL"},"studyFirstSubmitDate":"2024-04-15","studyFirstSubmitQcDate":"2024-04-15","studyFirstPostDateStruct":{"date":"2024-04-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-06-19","resultsFirstPostDateStruct":{"date":"2026-07-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-19","lastUpdatePostDateStruct":{"date":"2026-07-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant."},"conditionsModule":{"conditions":["Healthy"],"keywords":["Glucagon-Like Peptide (GLP)- 1"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Orforglipron + Carbamazepine","type":"EXPERIMENTAL","description":"Participants received study intervention through oral administration as follows:\n\n* Day 1: 1 milligram (mg) orforglipron capsule alone\n* Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets\n* Days 9 to 11: BID doses of 200 mg carbamazepine tablets\n* Days 12 to 14: BID doses of 300 mg carbamazepine tablets\n* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets\n* Days 16 to 18: BID doses of 300 mg carbamazepine tablets","interventionNames":["Drug: Orforglipron","Drug: Carbamazepine"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally","armGroupLabels":["Orforglipron + Carbamazepine"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Carbamazepine","description":"Administered orally","armGroupLabels":["Orforglipron + Carbamazepine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron","description":"PK: AUC (0-∞) of Orforglipron","timeFrame":"Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)"},{"measure":"PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron","description":"PK: AUC (0-tlast) of Orforglipron","timeFrame":"Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)"},{"measure":"PK: Maximum Observed Concentration (Cmax) of Orforglipron","description":"PK: Cmax of Orforglipron","timeFrame":"Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).\n* Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.\n* Have a hemoglobin level of\n\n  * at least 11.4 g/dL for individuals assigned female at birth (AFAB) and\n  * at least 12.5 g/dL for AMAB.\n* Have venous access sufficient to allow for blood sampling.\n\nExclusion Criteria:\n\n* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.\n* Have an abnormal 12-lead electrocardiogram (ECG).\n* Have human leucocyte antigen-B (HLA-B)\\*1502 or HLA-A\\*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.\n* Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.\n* Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"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)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"ICON Early Phase Services","city":"San Antonio","state":"Texas","zip":"78209","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Orforglipron + Carbamazepine","description":"Participants received study intervention through oral administration as follows:\n\n* Day 1: 1 milligram (mg) orforglipron capsule alone\n* Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets\n* Days 9 to 11: BID doses of 200 mg carbamazepine tablets\n* Days 12 to 14: BID doses of 300 mg carbamazepine tablets\n* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets\n* Days 16 to 18: BID doses of 300 mg carbamazepine tablets"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"Safety Population Day 1","comment":"All enrolled participants who received at least one dose of study intervention were included in the safety population.","achievements":[{"groupId":"FG000","comment":"As per the pre-specified statistical analysis plan, adverse events were reported for orforglipron alone (Day 1), carbamazepine alone regardless of dose received (Days 6-18 except Day 15), and orforglipron + carbamazepine combination (Day 15). Participants who received at least one dose of orforglipron alone = 30, carbamazepine alone = 29, and orforglipron + carbamazepine = 28.Two participants discontinued from the study on Days 4 and 11 respectively.","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants.","groups":[{"id":"BG000","title":"Orforglipron + Carbamazepine","description":"Participants received study intervention through oral administration as follows:\n\n* Day 1: 1 mg orforglipron capsule alone\n* Days 6 to 8: BID doses of 100 mg carbamazepine tablets\n* Days 9 to 11: BID doses of 200 mg carbamazepine tablets\n* Days 12 to 14: BID doses of 300 mg carbamazepine tablets\n* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets\n* Days 16 to 18: BID doses of 300 mg carbamazepine tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.0","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"24"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"21"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"12"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"17"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron","description":"PK: AUC (0-∞) of Orforglipron","populationDescription":"All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hours per milliliter(ng*h/mL)","timeFrame":"Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)","groups":[{"id":"OG000","title":"Orforglipron + Carbamazepine","description":"Participants received study intervention through oral administration as follows:\n\n* Day 1: 1 mg orforglipron capsule alone\n* Days 6 to 8: BID doses of 100 mg carbamazepine tablets\n* Days 9 to 11: BID doses of 200 mg carbamazepine tablets\n* Days 12 to 14: BID doses of 300 mg carbamazepine tablets\n* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets\n* Days 16 to 18: BID doses of 300 mg carbamazepine tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"title":"Day 1 (Orforglipron alone)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"104","spread":"26.6"}]}]},{"title":"Day 15 (Orforglipron + Carbamazepine)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"18.5","spread":"41.7"}]}]}]},{"type":"PRIMARY","title":"PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron","description":"PK: AUC (0-tlast) of Orforglipron","populationDescription":"All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hours per milliliter(ng*h/mL)","timeFrame":"Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); 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Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)","groups":[{"id":"OG000","title":"Orforglipron + Carbamazepine","description":"Participants received study intervention through oral administration as follows:\n\n* Day 1: 1 mg orforglipron capsule alone\n* Days 6 to 8: BID doses of 100 mg carbamazepine tablets\n* Days 9 to 11: BID doses of 200 mg carbamazepine tablets\n* Days 12 to 14: BID doses of 300 mg carbamazepine tablets\n* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets\n* Days 16 to 18: BID doses of 300 mg carbamazepine tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"title":"Day 1 (Orforglipron alone)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.97","spread":"31.0"}]}]},{"title":"Day 15 (Orforglipron + Carbamazepine)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.22","spread":"47.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to end of follow-up (up to 35 days)","description":"All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).","eventGroups":[{"id":"EG000","title":"Orforglipron Alone (Days 1-5)","description":"Participants observed for adverse events during Orforglipron alone on Day 1 and post-dose observation period (Days 2-5) prior to Carbamazepine initiation were reported under this arm.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":4,"otherNumAtRisk":30},{"id":"EG001","title":"Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)","description":"Participants observed for adverse events during Carbamazepine alone (Days 6-18 except Day 15) and follow-up period (Days 19-35) were reported under this arm.","deathsNumAffected":0,"deathsNumAtRisk":29,"seriousNumAffected":0,"seriousNumAtRisk":29,"otherNumAffected":12,"otherNumAtRisk":29},{"id":"EG002","title":"Orforglipron + Carbamazepine Combination (Day 15)","description":"Participants observed for adverse events during Orforglipron + Carbamazepine combination on Day 15 were reported under this arm.","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":2,"otherNumAtRisk":28}],"otherEvents":[{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":28}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":28}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":30},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":28}]},{"term":"Hyponatraemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Balance disorder","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]},{"term":"Drug eruption","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":28}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-595-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2024-01-31","uploadDate":"2026-04-16T17:46","filename":"Prot_000.pdf","size":1750458},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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