{"protocolSection":{"identificationModule":{"nctId":"NCT03322631","orgStudyIdInfo":{"id":"16400"},"secondaryIdInfos":[{"id":"I8F-JE-GPGC","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes","officialTitle":"A Multiple-Ascending Dose Study in Japanese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176"},"statusModule":{"statusVerifiedDate":"2022-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-11-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-05-29","type":"ACTUAL"},"completionDateStruct":{"date":"2018-11-28","type":"ACTUAL"},"studyFirstSubmitDate":"2017-10-24","studyFirstSubmitQcDate":"2017-10-24","studyFirstPostDateStruct":{"date":"2017-10-26","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2022-06-09","resultsFirstPostDateStruct":{"date":"2023-03-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-09","lastUpdatePostDateStruct":{"date":"2023-03-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purposes of this study are to determine:\n\n* The safety of tirzepatide and any side effects that might be associated with it.\n* How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.\n* How tirzepatide affects the levels of blood sugar.\n\nThis study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":48,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide","type":"EXPERIMENTAL","description":"Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered into the SC tissue of the abdominal wall.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC.","armGroupLabels":["Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.","timeFrame":"Baseline through Day 85"}],"secondaryOutcomes":[{"measure":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide","description":"Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.","timeFrame":"Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration"},{"measure":"PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide","description":"Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\\[0- τ\\]), where tau is dosing interval of (0-168 hours).","timeFrame":"Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration"},{"measure":"Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose","description":"Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM","timeFrame":"Baseline, Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase \\[DPP\\]-IV inhibitors)\n* Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive\n\nExclusion Criteria:\n\n* Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds\n* Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms\n* Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 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":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.","city":"Hachiōji","state":"Tokyo","zip":"192-0071","country":"Japan","geoPoint":{"lat":35.65583,"lon":139.32389}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.","city":"Shinjuku-Ku","state":"Tokyo","zip":"169-0073","country":"Japan"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"FG001","title":"2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)","description":"Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall."},{"id":"FG002","title":"5 mg/10 mg/15 mg Tirzepatide (Cohort 2)","description":"Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall."},{"id":"FG003","title":"5 mg Tirzepatide (Cohort 3)","description":"Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"11"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall."},{"id":"BG001","title":"2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)","description":"Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the SC tissue of the abdominal wall."},{"id":"BG002","title":"5 mg/10 mg/15 mg Tirzepatide (Cohort 2)","description":"Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall."},{"id":"BG003","title":"5 mg Tirzepatide (Cohort 3)","description":"Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"48"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.4","spread":"11.6"},{"groupId":"BG001","value":"56.9","spread":"9.5"},{"groupId":"BG002","value":"57.7","spread":"8.0"},{"groupId":"BG003","value":"57.5","spread":"7.9"},{"groupId":"BG004","value":"57.4","spread":"8.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"47"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"48"}]},{"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"}]}]}]},{"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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"48"}]},{"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"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"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"}]},{"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"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"48"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m²","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.58","spread":"2.09"},{"groupId":"BG001","value":"25.49","spread":"2.75"},{"groupId":"BG002","value":"26.10","spread":"3.11"},{"groupId":"BG003","value":"26.68","spread":"3.29"},{"groupId":"BG004","value":"25.42","spread":"3.16"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through Day 85","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo administered into the SC tissue of the abdominal wall."},{"id":"OG001","title":"2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)","description":"Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall."},{"id":"OG002","title":"5 mg/10 mg/15 mg Tirzepatide (Cohort 2)","description":"Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall."},{"id":"OG003","title":"5 mg Tirzepatide (Cohort 3)","description":"Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide","description":"Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.","populationDescription":"All randomized participants who received at least one dose of 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abdominal wall."},{"id":"OG002","title":"5 mg Tirzepatide (Cohort 3)","description":"Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"11"}]}],"classes":[{"title":"Day 1","categories":[{"measurements":[{"groupId":"OG000","value":"215","spread":"18"},{"groupId":"OG001","value":"442","spread":"23"},{"groupId":"OG002","value":"364","spread":"20"}]}]},{"title":"Day 50","categories":[{"measurements":[{"groupId":"OG000","value":"1520","spread":"15"},{"groupId":"OG001","value":"2270","spread":"17"},{"groupId":"OG002","value":"838","spread":"22"}]}]}]},{"type":"SECONDARY","title":"PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide","description":"Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\\[0- τ\\]), where tau is dosing interval of (0-168 hours).","populationDescription":"All randomized participants who received at least one dose of study drug and have evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms * hours per mL (ng*hr/mL)","timeFrame":"Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration","groups":[{"id":"OG000","title":"2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)","description":"Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall."},{"id":"OG001","title":"5 mg/10 mg/15 mg Tirzepatide (Cohort 2)","description":"Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for 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