{"protocolSection":{"identificationModule":{"nctId":"NCT04407234","orgStudyIdInfo":{"id":"17376"},"secondaryIdInfos":[{"id":"I8F-MC-GPHU","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide","officialTitle":"The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2023-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-09-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-07","type":"ACTUAL"},"completionDateStruct":{"date":"2021-01-07","type":"ACTUAL"},"studyFirstSubmitDate":"2020-05-27","studyFirstSubmitQcDate":"2020-05-27","studyFirstPostDateStruct":{"date":"2020-05-29","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-07","resultsFirstSubmitQcDate":"2023-04-11","resultsFirstPostDateStruct":{"date":"2024-01-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-11","lastUpdatePostDateStruct":{"date":"2024-01-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes.\n\nThe study will last about 13 weeks for each participant, including screening."},"conditionsModule":{"conditions":["Overweight","Obesity","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":36,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide + Acetaminophen","type":"EXPERIMENTAL","description":"Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.","interventionNames":["Drug: Tirzepatide","Drug: Acetaminophen"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Tirzepatide administered 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post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37"}],"secondaryOutcomes":[{"measure":"Hemoglobin A1c (HbA1c) Data by Diabetic Status","description":"Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64).","timeFrame":"Predose on Day 29 and follow-up (Day 64)"},{"measure":"PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic","description":"Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration \\[ AUC(0-tlast)\\] of Acetaminophen at Steady State For Non-diabetic","timeFrame":"Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37"},{"measure":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a 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37"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening\n* For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening\n* For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months\n* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff\n\nKey Exclusion Criteria\n\n* Have undergone gastric bypass or bariatric surgery\n* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening\n* For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months\n* Have any lifetime history of a suicide attempt\n* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study\n* Unwilling to comply with smoking and alcohol restrictions during the study","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 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":"Clinical Pharmacology of Miami","city":"Hialeah","state":"Florida","zip":"33014","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Related Info","url":"https://trials.lillytrialguide.com/en-US/trial/2VTN9N9xaJ4FhSAZuwJdif?conditionId=1wecF0AgauDdWnqHV7GJGP"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Non-Diabetic","description":"Participants received 5 milligrams (mg) tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37."},{"id":"FG001","title":"Type 2 Diabetes Mellitus (T2DM)","description":"Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Non-Diabetic","description":"Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37."},{"id":"BG001","title":"T2DM","description":"Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"36"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.9","spread":"10.8"},{"groupId":"BG001","value":"56.2","spread":"5.5"},{"groupId":"BG002","value":"50.1","spread":"10.5"}]}]}]},{"title":"Sex: Female, 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