{"protocolSection":{"identificationModule":{"nctId":"NCT04004988","orgStudyIdInfo":{"id":"17105"},"secondaryIdInfos":[{"id":"I8F-MC-GPGS","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants","officialTitle":"A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2023-04-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-08-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-12-16","type":"ACTUAL"},"completionDateStruct":{"date":"2019-12-16","type":"ACTUAL"},"studyFirstSubmitDate":"2019-06-28","studyFirstSubmitQcDate":"2019-06-28","studyFirstPostDateStruct":{"date":"2019-07-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2023-04-17","resultsFirstPostDateStruct":{"date":"2023-04-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-17","lastUpdatePostDateStruct":{"date":"2023-04-18","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 given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.\n\nScreening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":47,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide Test","type":"EXPERIMENTAL","description":"Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.","interventionNames":["Drug: Tirzepatide","Device: Auto-injector (AI)"]},{"label":"Tirzepatide Reference","type":"EXPERIMENTAL","description":"Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.","interventionNames":["Drug: Tirzepatide","Device: Prefilled syringe (PFS)"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["Tirzepatide Reference","Tirzepatide Test"],"otherNames":["LY3298176"]},{"type":"DEVICE","name":"Prefilled syringe (PFS)","description":"PFS used to administer tirzepatide","armGroupLabels":["Tirzepatide Reference"]},{"type":"DEVICE","name":"Auto-injector (AI)","description":"AI used to administer tirzepatide","armGroupLabels":["Tirzepatide Test"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.","timeFrame":"Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose"},{"measure":"PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide","description":"PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported","timeFrame":"Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose"}]},"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 18.0 and 32.0 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 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":"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 Nus Centre for Clin Pharmacology","city":"Singapore","zip":"138623","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sequence A","description":"Participants received single dose of 5 milligram (mg) tirzepatide by subcutaneous injection (SC) administered through autoinjector on day 1 of period 1.\n\nParticipants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 2."},{"id":"FG001","title":"Sequence B","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 1.\n\nParticipants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector on day 1 of period 2."}],"periods":[{"title":"Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"23"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"23"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]},{"title":"Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"All Participants","description":"Participants received 5mg of tirzepatide by SC injection administered by autoinjector or prefilled syringe on day 1 of each period as per the dosing sequence."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"47"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.6","spread":"11.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"}]},{"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":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"47"}]},{"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":"47"}]},{"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":"47"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK samples.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose","groups":[{"id":"OG000","title":"5 mg Tirzepatide AI","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector."},{"id":"OG001","title":"5 mg Tirzepatide PFS","description":"Participants received single dose of 5mg tirzepatide by SC injection administered through prefilled syringe."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"101000","spread":"18"},{"groupId":"OG001","value":"104000","spread":"18"}]}]}]},{"type":"PRIMARY","title":"PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide","description":"PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK samples.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Nanogram per Milliliter (ng/mL)","timeFrame":"Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose","groups":[{"id":"OG000","title":"5 mg Tirzepatide AI","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector."},{"id":"OG001","title":"5 mg Tirzepatide PFS","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"44"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"530","spread":"25"},{"groupId":"OG001","value":"556","spread":"22"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to 72 days","description":"All participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide AI","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.","deathsNumAffected":0,"deathsNumAtRisk":42,"seriousNumAffected":0,"seriousNumAtRisk":42,"otherNumAffected":40,"otherNumAtRisk":42},{"id":"EG001","title":"5 mg Tirzepatide PFS","description":"Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe.","deathsNumAffected":0,"deathsNumAtRisk":44,"seriousNumAffected":1,"seriousNumAtRisk":44,"otherNumAffected":42,"otherNumAtRisk":44}],"seriousEvents":[{"term":"Catheter site phlebitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44}]}],"otherEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":21,"numAffected":20,"numAtRisk":42},{"groupId":"EG001","numEvents":34,"numAffected":29,"numAtRisk":44}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":44}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":42},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":44}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":14,"numAtRisk":42},{"groupId":"EG001","numEvents":13,"numAffected":12,"numAtRisk":44}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":26,"numAffected":14,"numAtRisk":42},{"groupId":"EG001","numEvents":31,"numAffected":16,"numAtRisk":44}]},{"term":"Catheter site bruise","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":44}]},{"term":"Catheter site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":42},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":44}]},{"term":"Catheter site phlebitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Catheter site swelling","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Vessel puncture site bruise","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":7,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44}]},{"term":"Vessel puncture site phlebitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Viral upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":24,"numAffected":24,"numAtRisk":42},{"groupId":"EG001","numEvents":22,"numAffected":22,"numAtRisk":44}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":44}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":8,"numAtRisk":42},{"groupId":"EG001","numEvents":12,"numAffected":11,"numAtRisk":44}]},{"term":"Lethargy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]},{"term":"Dry throat","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":44}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":44}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":44}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2019-06-04","uploadDate":"2020-07-15T04:14","filename":"Prot_000.pdf","size":4375931},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2019-08-09","uploadDate":"2020-07-15T04:15","filename":"SAP_001.pdf","size":404230}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"D000098860","term":"Tirzepatide"}],"ancestors":[{"id":"D000067757","term":"Glucagon-Like Peptide-1 Receptor"},{"id":"D000067756","term":"Glucagon-Like Peptide Receptors"},{"id":"D043562","term":"Receptors, G-Protein-Coupled"},{"id":"D011956","term":"Receptors, Cell Surface"},{"id":"D008565","term":"Membrane Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"}]}},"hasResults":true}