{"protocolSection":{"identificationModule":{"nctId":"NCT03375463","orgStudyIdInfo":{"id":"16671"},"secondaryIdInfos":[{"id":"I8F-MC-GPGE","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Healthy Participants","officialTitle":"Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2024-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-12-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-12-27","type":"ACTUAL"},"completionDateStruct":{"date":"2018-12-27","type":"ACTUAL"},"studyFirstSubmitDate":"2017-12-13","studyFirstSubmitQcDate":"2017-12-13","studyFirstPostDateStruct":{"date":"2017-12-18","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2024-02-02","resultsFirstPostDateStruct":{"date":"2024-02-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-02-02","lastUpdatePostDateStruct":{"date":"2024-02-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study has four parts. Each participant will enroll in one part.\n\nPart A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.\n\nPart B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.\n\nPart C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.\n\nPart D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.\n\nThis study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Part A, B and D are not blinded. Part C is blinded to Participant and Investigator","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":52,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide SC (Solution)-Part A","type":"EXPERIMENTAL","description":"Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation.","interventionNames":["Drug: Tirzepatide"]},{"label":"5 mg Tirzepatide SC (Lyophilized)-Part A","type":"EXPERIMENTAL","description":"Participants received 5 mg of tirzepatide SC lyophilized formulation.","interventionNames":["Drug: Tirzepatide"]},{"label":"0.5 mg LY3298176 IV-Part B","type":"EXPERIMENTAL","description":"Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation.","interventionNames":["Drug: Tirzepatide"]},{"label":"5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C","type":"EXPERIMENTAL","description":"Participants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo SC-Part C","type":"PLACEBO_COMPARATOR","description":"Participants received SC injection of placebo.","interventionNames":["Drug: Placebo"]},{"label":"0.5 mg LY3298176 Bolus IV-Part D","type":"EXPERIMENTAL","description":"Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.","interventionNames":["Drug: Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["5 mg Tirzepatide SC (Lyophilized)-Part A","5 mg Tirzepatide SC (Solution)-Part A","5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Tirzepatide","description":"Administered IV","armGroupLabels":["0.5 mg LY3298176 IV-Part B"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo SC-Part C"]},{"type":"DRUG","name":"Tirzepatide","description":"Administered IV","armGroupLabels":["0.5 mg LY3298176 Bolus IV-Part D"],"otherNames":["LY3298176"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide","description":"Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \\[AUC (0-∞)\\] of tirzepatide.","timeFrame":"Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose"},{"measure":"PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide","description":"PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.","timeFrame":"Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose"},{"measure":"PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide","description":"PK Part B: Area under the concentration versus time curve \\[AUC (0-∞)\\] of tirzepatide.","timeFrame":"Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose"}],"secondaryOutcomes":[{"measure":"PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide","description":"PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) \\[AUC (0-τ)\\] of tirzepatide.","timeFrame":"Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose"},{"measure":"PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide","description":"PK Part C: Maximum observed plasma drug concentration (Cmax) of tirzepatide.","timeFrame":"Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose"},{"measure":"PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide","description":"PK Part D: Area under the concentration versus time curve \\[AUC (0-∞)\\] of tirzepatide.","timeFrame":"Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Overtly healthy males or females, as determined by medical history and physical examination\n* Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product\n* Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state\n* Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive\n\nExclusion Criteria:\n\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n* Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening\n* Have a history of heart block, or a pulse rate (PR) interval greater than (\\>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data","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","city":"Dallas","state":"Texas","zip":"75247","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"4-part study, Part A (2-period, 2-treatment, crossover study with at least 35 days of washout period), Part B (fixed, single-arm treatment study), Part C (placebo-controlled, 4-week dose escalation study) and Part D (a fixed, single-arm treatment study).","groups":[{"id":"FG000","title":"Sequence 1-Part A","description":"Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2."},{"id":"FG001","title":"Sequence 2-Part A","description":"Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2."},{"id":"FG002","title":"0.5 mg Tirzepatide IV-Part B","description":"Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation."},{"id":"FG003","title":"Placebo SC-Part C","description":"Participants received SC injection of placebo."},{"id":"FG004","title":"5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C","description":"Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4)."},{"id":"FG005","title":"0.5 mg Tirzepatide Bolus IV-Part D","description":"Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation."}],"periods":[{"title":"Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"8"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]}]},{"title":"Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","comment":"Part B was planned as a single Period study.","numSubjects":"0"},{"groupId":"FG003","comment":"Part C was planned as a single Period study.","numSubjects":"0"},{"groupId":"FG004","comment":"Part C was planned as a single Period study.","numSubjects":"0"},{"groupId":"FG005","comment":"Part D was planned as a single Period study.","numSubjects":"0"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants","groups":[{"id":"BG000","title":"Sequence 1-Part A","description":"Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2."},{"id":"BG001","title":"Sequence 2-Part A","description":"Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2."},{"id":"BG002","title":"0.5 mg Tirzepatide IV-Part B","description":"Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation."},{"id":"BG003","title":"Placebo SC-Part C","description":"Participants received SC injection of placebo."},{"id":"BG004","title":"5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C","description":"Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4)."},{"id":"BG005","title":"0.5 mg Tirzepatide Bolus IV-Part D","description":"Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation."},{"id":"BG006","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"12"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"52"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"11"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"51"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"37"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"9"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"11"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"43"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","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"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"29"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"20"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"12"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"52"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide","description":"Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \\[AUC (0-∞)\\] of tirzepatide.","populationDescription":"All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hours per milliliter(ng*hr/mL)","timeFrame":"Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose","groups":[{"id":"OG000","title":"5 mg Tirzepatide SC (Lyophilized)-Part A","description":"Participants received 5 mg of tirzepatide SC lyophilized formulation."},{"id":"OG001","title":"5 mg Tirzepatide SC (Solution)-Part A","description":"Participants received 5 mg of tirzepatide SC solution formulation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"113000","spread":"19"},{"groupId":"OG001","value":"109000","spread":"17"}]}]}]},{"type":"PRIMARY","title":"PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide","description":"PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.","populationDescription":"All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms per milliliter (ng/mL)","timeFrame":"Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose","groups":[{"id":"OG000","title":"5 mg Tirzepatide SC (Lyophilized)-Part A","description":"Participants received 5 mg of tirzepatide SC lyophilized formulation."},{"id":"OG001","title":"5 mg Tirzepatide SC (Solution)-Part A","description":"Participants received 5 mg of tirzepatide SC solution formulation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"524","spread":"27"},{"groupId":"OG001","value":"575","spread":"22"}]}]}]},{"type":"PRIMARY","title":"PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide","description":"PK Part B: Area under the concentration versus time curve \\[AUC (0-∞)\\] of tirzepatide.","populationDescription":"All randomized participants from Part B group, who received at least one dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose","groups":[{"id":"OG000","title":"0.5 mg Tirzepatide IV-Part B","description":"Participants received IV infusion of a single 0.5 mg dose of tirzepatide solution formulation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6680","spread":"26"}]}]}]},{"type":"SECONDARY","title":"PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide","description":"PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) \\[AUC (0-τ)\\] of tirzepatide.","populationDescription":"All randomized participants from Part C group, who received at least one dose of study drug and had evaluable PK data. As per planned analysis, for 10 mg Tirzepatide SC-Part C arm, no PK samples were collected at 168 hour post dose (after the fourth dose. i.e. following dose at Week 4). 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