{"protocolSection":{"identificationModule":{"nctId":"NCT05978713","orgStudyIdInfo":{"id":"18614"},"secondaryIdInfos":[{"id":"I8F-MC-GPIN","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Healthy Lactating Females","officialTitle":"A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females"},"statusModule":{"statusVerifiedDate":"2025-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-07-31","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-03-12","type":"ACTUAL"},"completionDateStruct":{"date":"2024-03-12","type":"ACTUAL"},"studyFirstSubmitDate":"2023-07-31","studyFirstSubmitQcDate":"2023-07-31","studyFirstPostDateStruct":{"date":"2023-08-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-03-06","resultsFirstSubmitQcDate":"2025-04-09","resultsFirstPostDateStruct":{"date":"2025-04-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-04-09","lastUpdatePostDateStruct":{"date":"2025-04-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":11,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC).","interventionNames":["Drug: Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["5 mg Tirzepatide"],"otherNames":["LY3298176"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])","description":"PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk","timeFrame":"Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants who are overtly healthy females as determined by medical evaluation\n* Female participants who delivered normal-term infant (at least 37 weeks gestation) and are at least 6 weeks postpartum at the time of screening\n* Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²), inclusive\n* Female participants who has well-established lactation and is breastfeeding her infant. Note: Breastfeeding must be discontinued prior to the administration of tirzepatide on Day 1 and not resumed for the remaining duration of the study until a follow-up visit (or for total of 29 days after tirzepatide dosing for participants who discontinue early).\n\nExclusion Criteria:\n\n* Have a history of inadequate lactation (for multiparous females who have previously breastfed)\n* Have confirmed type 1 or type 2 diabetes mellitus\n* Regularly use known drugs of abuse or show positive findings on drug screen","healthyVolunteers":true,"sex":"FEMALE","genderBased":true,"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":"Las Vegas Clinical Research Unit - PPD","city":"Las Vegas","state":"Nevada","zip":"89113-2228","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5 mg Tirzepatide","description":"Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"Received a Dose of Tirzepatide","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"Participants received a single dose of 5 mg tirzepatide injection administered SC."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.7","spread":"4.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"8"}]},{"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":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"7"}]},{"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 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SC."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","spread":"NA","comment":"For all participants, insufficient quantifiable concentrations, due to data below the level of detection, were available after the maximum observed drug concentration (Cmax) to calculate the elimination phase parameters for breastmilk. Therefore, AUC(0-∞) in breastmilk was not calculated."}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline to the end of follow-up (up to Day 29)","description":"All enrolled participants who received a dose of Tirzepatide.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"Participants received a single dose of 5 mg tirzepatide injection administered SC.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":11,"otherNumAtRisk":11}],"otherEvents":[{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":11}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":11}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":11}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":9,"numAtRisk":11}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":11}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":11}]},{"term":"Seasonal 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disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":11}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":11}]},{"term":"Lethargy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Abnormal dreams","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11}]}]},"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":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2023-09-15","uploadDate":"2025-03-05T10:14","filename":"Prot_000.pdf","size":733374},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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