{"protocolSection":{"identificationModule":{"nctId":"NCT05573230","orgStudyIdInfo":{"id":"18506"},"secondaryIdInfos":[{"id":"J2A-MC-GZGL","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants","officialTitle":"A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-10-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-01-17","type":"ACTUAL"},"completionDateStruct":{"date":"2023-01-17","type":"ACTUAL"},"studyFirstSubmitDate":"2022-10-07","studyFirstSubmitQcDate":"2022-10-07","studyFirstPostDateStruct":{"date":"2022-10-10","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":32,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Midazolam + LY3502970","type":"EXPERIMENTAL","description":"Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.","interventionNames":["Drug: Midazolam","Drug: LY3502970"]},{"label":"Cyclosporine + Midazolam + LY3502970","type":"EXPERIMENTAL","description":"Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.","interventionNames":["Drug: Midazolam","Drug: LY3502970","Drug: Cyclosporine"]}],"interventions":[{"type":"DRUG","name":"Midazolam","description":"Administered orally.","armGroupLabels":["Cyclosporine + Midazolam + LY3502970","Midazolam + LY3502970"]},{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["Cyclosporine + Midazolam + LY3502970","Midazolam + LY3502970"]},{"type":"DRUG","name":"Cyclosporine","description":"Administered orally.","armGroupLabels":["Cyclosporine + Midazolam + LY3502970"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970","description":"PK: AUC of LY3502970","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose"},{"measure":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation\n* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)\n* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants\n* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential\n\nExclusion Criteria:\n\n* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs\n* Participants who regularly use known drugs of abuse\n* Women who are lactating and who are of child-bearing potential\n* Participants who have known allergies to LY3502970, 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":"Lilly Centre for Clinical Pharmacology","city":"Singapore","zip":"138623","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"This is a 2-period single arm study with a washout period of at least 14 days between Period 1 and Period 2.","groups":[{"id":"FG000","title":"Midazolam + Cyclosporine + LY3502970","description":"Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, followed by 3 mg LY3502970 capsule given orally on Day 1.\n\nPeriod 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20."}],"periods":[{"title":"Midazolam + LY3502970 (Period 1)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"32"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"31"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]},{"title":"Cyclosporine + LY3502970 (Period 2)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Midazolam + Cyclosporine + LY3502970","description":"Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, 16, 19 followed by 3 mg LY3502970 capsule given orally on Day 1.\n\nPeriod 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"31"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.3","spread":"11.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"27"}]}]}]},{"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":"31"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"}]},{"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":"Singapore","categories":[{"measurements":[{"groupId":"BG000","value":"31"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970","description":"PK: AUC of LY3502970","populationDescription":"All participants who received at least one dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram * hour per milliliter (ng*hr/mL","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose","groups":[{"id":"OG000","title":"LY3502970 (Reference)","description":"Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1."},{"id":"OG001","title":"Cyclosporine + LY3502970 (Test)","description":"Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"332","spread":"39"},{"groupId":"OG001","value":"857","spread":"51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Least Square (LS) Mean","nonInferiorityType":"OTHER","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Ratio","paramValue":"2.55","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.07","ciUpperLimit":"3.14"}]},{"type":"PRIMARY","title":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970","populationDescription":"All participants who received at least one dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter (ng/mL)","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose","groups":[{"id":"OG000","title":"LY3502970 (Reference)","description":"Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1, followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1."},{"id":"OG001","title":"Cyclosporine + LY3502970 (Test)","description":"Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.9","spread":"48"},{"groupId":"OG001","value":"18.4","spread":"36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Ratio","paramValue":"1.29","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.00","ciUpperLimit":"1.66"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to 76 days","description":"All participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"200 ug Midazolam","description":"200 ug midazolam administered as oral solution \\[5 milligrams (mg) per milliliter (mL) solution ampoule\\] on -1 Day","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":4,"otherNumAtRisk":31},{"id":"EG001","title":"3 mg LY3502970 (Reference)","description":"3 mg LY3502970 capsule given orally on Day 1 in Period 1.","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":28,"otherNumAtRisk":31},{"id":"EG002","title":"200 mg Cyclosporine BID + 200 ug Midazolam","description":"200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 200 µg midazolam administered as oral solution on Days 16 and 19","deathsNumAffected":0,"deathsNumAtRisk":24,"seriousNumAffected":0,"seriousNumAtRisk":24,"otherNumAffected":18,"otherNumAtRisk":24},{"id":"EG003","title":"200 mg Cyclosporine BID + 3 mg LY3502970 (Test)","description":"200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 3 mg LY3502970 on Day 17.","deathsNumAffected":0,"deathsNumAtRisk":24,"seriousNumAffected":0,"seriousNumAtRisk":24,"otherNumAffected":22,"otherNumAtRisk":24},{"id":"EG004","title":"200 mg Cyclosporine","description":"Single oral dose 200 mg (2 - 100 mg) cyclosporine capsules on Day 20.","deathsNumAffected":0,"deathsNumAtRisk":25,"seriousNumAffected":0,"seriousNumAtRisk":25,"otherNumAffected":20,"otherNumAtRisk":25}],"otherEvents":[{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":24},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG004","numEvents":4,"numAffected":3,"numAtRisk":25}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG001","numEvents":12,"numAffected":11,"numAtRisk":31},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG003","numEvents":10,"numAffected":10,"numAtRisk":24},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":25}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":12,"numAffected":11,"numAtRisk":31},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG003","numEvents":9,"numAffected":9,"numAtRisk":24},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":25}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":30,"numAffected":13,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":35,"numAffected":13,"numAtRisk":24},{"groupId":"EG004","numEvents":11,"numAffected":5,"numAtRisk":25}]},{"term":"Catheter site bruise","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":31},{"groupId":"EG002","numEvents":5,"numAffected":4,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":5,"numAffected":5,"numAtRisk":25}]},{"term":"Catheter site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":31},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":31},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":24},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":25}]},{"term":"Catheter site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":25}]},{"term":"Catheter site phlebitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":24},{"groupId":"EG004","numEvents":5,"numAffected":4,"numAtRisk":25}]},{"term":"Catheter site pruritus","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Catheter site swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":24},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":25}]},{"term":"Chills","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":25}]},{"term":"Feeling hot","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":8,"numAffected":8,"numAtRisk":25}]},{"term":"Vessel puncture site bruise","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":5,"numAffected":4,"numAtRisk":31},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":31},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":31},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG003","numEvents":11,"numAffected":11,"numAtRisk":24},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":25}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":25}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":25}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":31},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":24},{"groupId":"EG004","numEvents":4,"numAffected":4,"numAtRisk":25}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":25}]},{"term":"Hot flush","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":24},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":25}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"8005955979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2022-09-13","uploadDate":"2023-11-20T15:00","filename":"Prot_000.pdf","size":1247007},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2023-04-04","uploadDate":"2023-11-20T15:01","filename":"SAP_001.pdf","size":408218}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"D008874","term":"Midazolam"},{"id":"C000729680","term":"orforglipron"},{"id":"D016572","term":"Cyclosporine"}],"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":"D003524","term":"Cyclosporins"},{"id":"D010456","term":"Peptides, Cyclic"},{"id":"D047028","term":"Macrocyclic Compounds"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"}]}},"hasResults":true}