{"protocolSection":{"identificationModule":{"nctId":"NCT04050670","orgStudyIdInfo":{"id":"17224"},"secondaryIdInfos":[{"id":"I8F-MC-GPHI","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes","officialTitle":"Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices"},"statusModule":{"statusVerifiedDate":"2023-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-09-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-04-03","type":"ACTUAL"},"completionDateStruct":{"date":"2020-04-03","type":"ACTUAL"},"studyFirstSubmitDate":"2019-08-07","studyFirstSubmitQcDate":"2019-08-07","studyFirstPostDateStruct":{"date":"2019-08-08","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2022-06-09","resultsFirstPostDateStruct":{"date":"2023-03-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-10","lastUpdatePostDateStruct":{"date":"2023-05-06","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 compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":54,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide - Upper Arm","type":"EXPERIMENTAL","description":"Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.","interventionNames":["Drug: Tirzepatide"]},{"label":"Tirzepatide - Thigh","type":"EXPERIMENTAL","description":"Participants received 5mg Tirzepatide by subcutaneous injection on thigh.","interventionNames":["Drug: Tirzepatide"]},{"label":"Tirzepatide - Abdomen","type":"ACTIVE_COMPARATOR","description":"Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.","interventionNames":["Drug: Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Tirzepatide administered SC","armGroupLabels":["Tirzepatide - Abdomen","Tirzepatide - Thigh","Tirzepatide - Upper Arm"],"otherNames":["LY3298176"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC\\[0-∞\\]) was evaluated.","timeFrame":"Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose"},{"measure":"PK: Maximum Concentration (Cmax) of Tirzepatide","description":"PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.","timeFrame":"Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures\n* Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening\n* Are agreeable to receiving study treatment by injections under the skin\n\nExclusion Criteria:\n\n* Have known allergies to tirzepatide or related compounds\n* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2\n* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors\n* Have a prior history of malignant disease(s) in the past 5 years prior to screening\n* Smoke more than the equivalent of 10 cigarettes per day\n* Is a known user of drugs of abuse","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 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":"Covance Clinical Research Inc","city":"Daytona Beach","state":"Florida","zip":"32117","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"There was a washout period of at least 35 days between Tirzepatide injections.","groups":[{"id":"FG000","title":"Sequence 1","description":"Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on upper arm in period 1, on thigh in period 2 and on abdomen in period 3."},{"id":"FG001","title":"Sequence 2","description":"Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on abdomen in period 1, on upper arm in period 2 and on thigh in period 3."},{"id":"FG002","title":"Sequence 3","description":"Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on thigh in period 1, on abdomen in period 2 and on upper arm in period 3."}],"periods":[{"title":"Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"Received at Least One Dose","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Period 3","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"Received at Least One Dose","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"All Participants","description":"Participants received 5mg Tirzepatide by subcutaneous injection administered through either upper arms or abdomen or thigh as per the dosing sequence."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"54"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.1","spread":"12.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"17"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"37"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"16"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"38"}]},{"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":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"14"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"40"}]},{"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","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"54"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC\\[0-∞\\]) was evaluated.","populationDescription":"All randomized 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thigh."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"112000","spread":"24"},{"groupId":"OG001","value":"111000","spread":"21"},{"groupId":"OG002","value":"106000","spread":"22"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25","statisticalMethod":"Linear mixed effects model","paramType":"Ratio of geometric least squares mean","paramValue":"0.953","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.935","ciUpperLimit":"0.970"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"A priori estimates for the 90% CI geometric least square means ratios of 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22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":54},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":54},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":53}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":21,"numAffected":20,"numAtRisk":54},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":54},{"groupId":"EG002","numEvents":12,"numAffected":11,"numAtRisk":53}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":9,"numAtRisk":54},{"groupId":"EG001","numEvents":10,"numAffected":10,"numAtRisk":54},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":53}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":54},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":54},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":53}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":13,"numAtRisk":54},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":54},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":53}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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