{"protocolSection":{"identificationModule":{"nctId":"NCT03363906","orgStudyIdInfo":{"id":"16878"},"secondaryIdInfos":[{"id":"H9X-MC-GBGM","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dulaglutide in Healthy Participants","officialTitle":"Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2018-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-12-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-06-06","type":"ACTUAL"},"completionDateStruct":{"date":"2018-06-06","type":"ACTUAL"},"studyFirstSubmitDate":"2017-12-01","studyFirstSubmitQcDate":"2017-12-01","studyFirstPostDateStruct":{"date":"2017-12-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-05-24","resultsFirstSubmitQcDate":"2019-07-26","resultsFirstPostDateStruct":{"date":"2019-07-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-07-26","lastUpdatePostDateStruct":{"date":"2019-07-29","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 evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe.\n\nThis study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.\n\nThe study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU)."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":27,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Dulaglutide (Reference)","type":"EXPERIMENTAL","description":"Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods","interventionNames":["Drug: Dulaglutide (Reference)"]},{"label":"Dulaglutide (Test)","type":"EXPERIMENTAL","description":"Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods","interventionNames":["Drug: Dulaglutide (Test)"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide (Reference)","description":"Administered SC","armGroupLabels":["Dulaglutide (Reference)"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Dulaglutide (Test)","description":"Administered SC","armGroupLabels":["Dulaglutide (Test)"],"otherNames":["LY2189265"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide","description":"Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\\[0-∞\\]) of Dulaglutide.","timeFrame":"Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28"},{"measure":"PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide","description":"Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.","timeFrame":"Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Overtly healthy as determined by medical history and physical examination at time of screening\n* Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive\n\nExclusion Criteria:\n\n* Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related compounds, or any components of the formulation\n* Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC\n* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 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 Dallas","city":"Dallas","state":"Texas","zip":"75247","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.","groups":[{"id":"FG000","title":"Sequence A Dulaglutide (Reference) Then Dulaglutide (Test)","description":"Dulaglutide (4.5 milligram \\[mg\\]) administered subcutaneously (SC) in 3 prefilled syringes (PFS) in period 1 and then dulaglutide 4.5 mg administered SC in single dose pen (SDP) in period 2."},{"id":"FG001","title":"Sequence B Dulaglutide (Test) Then Dulaglutide (Reference)","description":"Dulaglutide 4.5 mg administered SC in one (SDP) in period 1 and then Dulaglutide 4.5 mg administered SC (PFS) in period 2."}],"periods":[{"title":"Period 1 (Reference or Test)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]},{"title":"Period 2 (Test or Reference)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants","groups":[{"id":"BG000","title":"Dulaglutide Test and Reference","description":"Dulaglutide 4.5 mg administered SC in 3 prefilled syringes and 1 single dose pen in one of two study periods."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.7","spread":"10.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"12"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"}]},{"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":"22"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"5"}]},{"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":"27"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide","description":"Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\\[0-∞\\]) of Dulaglutide.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram.hour/milliliter (ng.h/mL)","timeFrame":"Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28","groups":[{"id":"OG000","title":"Dulaglutide (Reference)","description":"Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods"},{"id":"OG001","title":"Dulaglutide (Test)","description":"Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37400","spread":"38"},{"groupId":"OG001","value":"40000","spread":"33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.473","statisticalMethod":"Mixed Models Analysis","paramType":"Ratio Geometric Least Squares (LS) Mean","paramValue":"1.04","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.949","ciUpperLimit":"1.14"}]},{"type":"PRIMARY","title":"PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide","description":"Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of 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18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":24},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":23}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":11,"numAtRisk":24},{"groupId":"EG001","numEvents":15,"numAffected":12,"numAtRisk":23}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":24},{"groupId":"EG001","numEvents":9,"numAffected":7,"numAtRisk":23}]},{"term":"Injection site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":24},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":23}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":24},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":23}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":24},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":23}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2017-12-06","uploadDate":"2019-07-25T14:16","filename":"SAP_000.pdf","size":358251},{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2017-09-24","uploadDate":"2019-07-25T14:17","filename":"Prot_001.pdf","size":758925}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"C555680","term":"dulaglutide"}]}},"hasResults":true}