{"protocolSection":{"identificationModule":{"nctId":"NCT02759107","orgStudyIdInfo":{"id":"16119"},"secondaryIdInfos":[{"id":"I8F-MC-GPGA","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)","officialTitle":"A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2023-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-05-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-06-26","type":"ACTUAL"},"completionDateStruct":{"date":"2017-06-26","type":"ACTUAL"},"studyFirstSubmitDate":"2016-04-29","studyFirstSubmitQcDate":"2016-04-29","studyFirstPostDateStruct":{"date":"2016-05-03","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2023-04-17","resultsFirstPostDateStruct":{"date":"2024-01-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-17","lastUpdatePostDateStruct":{"date":"2024-01-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The main 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 get rid of it.\n* How tirzepatide affects the levels of blood sugar.\n\nThis study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part.\n\nThis study is for research purposes only, and is not intended to treat any medical condition."},"conditionsModule":{"conditions":["Healthy","Type 2 Diabetes Mellitus (T2DM)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":142,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide (Part A)","type":"EXPERIMENTAL","description":"Participants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo (Part A)","type":"PLACEBO_COMPARATOR","description":"Participants received single dose of placebo by subcutaneous injection.","interventionNames":["Drug: Placebo"]},{"label":"Tirzepatide (Part B)","type":"EXPERIMENTAL","description":"Participants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo (Part B)","type":"PLACEBO_COMPARATOR","description":"Participants received placebo once weekly for four weeks by subcutaneous injection.","interventionNames":["Drug: Placebo"]},{"label":"Dulaglutide (Part B)","type":"ACTIVE_COMPARATOR","description":"Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.","interventionNames":["Drug: Dulaglutide"]},{"label":"Tirzepatide (Part C)","type":"EXPERIMENTAL","description":"Participants received fixed doses of either 0.5mg or 5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo (Part C)","type":"PLACEBO_COMPARATOR","description":"Participants received placebo once weekly for four weeks by subcutaneous injection.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["Tirzepatide (Part A)","Tirzepatide (Part B)","Tirzepatide (Part C)"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo (Part A)","Placebo (Part B)","Placebo (Part C)"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["Dulaglutide (Part B)"],"otherNames":["Trulicity®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With One or More Serious Adverse Event(s) (SAEs)","description":"Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module","timeFrame":"Baseline through Day 43 (Part A) and Day 57 (Part B and C)"}],"secondaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.","description":"Area under the concentration versus time curve from zero to infinity (AUC \\[0-∞\\]) of Tirzepatide in Part A.","timeFrame":"Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43"},{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B","description":"Area under the concentration versus time curve during 1 dosing interval (AUC \\[0-τ\\]) of Tirzepatide in Part B. τ equals 168 hours.","timeFrame":"Predose, 8hours(h), 24h,48h,72h,168h postdose"},{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C","description":"Area under the concentration versus time curve during 1 dosing interval (AUC \\[0-τ\\]) of Tirzepatide in Part C. τ equals 168 hours.","timeFrame":"Predose, 8hours(h), 24h,48h,72h,168h postdose"},{"measure":"Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)","description":"PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\\[0-2h\\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).","timeFrame":"Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2"},{"measure":"Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)","description":"PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\\[0-2h\\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).","timeFrame":"Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)\n* Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive\n* Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug\n\nExclusion Criteria:\n\n* Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds\n* Have an 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 history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal \\[ULN\\]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, 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 (DPP)-IV inhibitors\n\nParticipants with T2DM (Part C only)\n\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\nAll Study Participants (Parts B and C only)\n\n* have known allergies to tirzepatide, GLP-1 analogs, or related compounds, or acetaminophen","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":"Miami Research Associates","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"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":"Singapore","zip":"117597","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"referencesModule":{"references":[{"pmid":"30473097","type":"DERIVED","citation":"Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3."}],"seeAlsoLinks":[{"label":"Click here for more information about this study:A Study of tirzepatide in Participants With Type 2 Diabetes (T2DM)","url":"https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/GPGA#?postal="}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Part A Placebo","description":"Participants received placebo by subcutaneous (SC) injection."},{"id":"FG001","title":"Part A 0.25 mg Tirzepatide","description":"Participants received single dose of 0.25 milligram (mg) Tirzepatide by subcutaneous injection."},{"id":"FG002","title":"Part A 0.5mg Tirzepatide","description":"Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection."},{"id":"FG003","title":"Part A 1mg Tirzepatide","description":"Participants received single dose of 1mg Tirzepatide by subcutaneous injection."},{"id":"FG004","title":"Part A 2.5mg Tirzepatide","description":"Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection."},{"id":"FG005","title":"Part A 5mg Tirzepatide","description":"Participants received single dose of 5mg Tirzepatide by subcutaneous injection."},{"id":"FG006","title":"Part A 8mg Tirzepatide","description":"Participants received single dose of 8mg Tirzepatide by subcutaneous injection."},{"id":"FG007","title":"Part B Placebo","description":"Participants received placebo by subcutaneous injection."},{"id":"FG008","title":"Part B 1.5mg Dulaglutide","description":"Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection."},{"id":"FG009","title":"Part B 0.5mg Tirzepatide","description":"Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG010","title":"Part B 1.5mg Tirzepatide","description":"Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG011","title":"Part B 4.5mg Tirzepatide","description":"Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections."},{"id":"FG012","title":"Part B 5, 5, 8,10mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW."},{"id":"FG013","title":"Part C Placebo","description":"Participants received placebo by subcutaneous injection."},{"id":"FG014","title":"Part C 0.5mg Tirzepatide","description":"Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG015","title":"Part C 5mg Tirzepatide","description":"Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG016","title":"Part C 5, 5, 10,10mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW."},{"id":"FG017","title":"Part C 5, 5, 10,15mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW."}],"periods":[{"title":"Overall 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COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"2"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"0"},{"groupId":"FG015","numSubjects":"1"},{"groupId":"FG016","numSubjects":"0"},{"groupId":"FG017","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse 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Tirzepatide","description":"Participants received single dose of 0.25mg Tirzepatide by subcutaneous injection."},{"id":"BG002","title":"Part A 0.5mg Tirzepatide","description":"Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection."},{"id":"BG003","title":"Part A 1mg Tirzepatide","description":"Participants received single dose of 1mg Tirzepatide by subcutaneous injection."},{"id":"BG004","title":"Part A 2.5mg Tirzepatide","description":"Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection."},{"id":"BG005","title":"Part A 5mg Tirzepatide","description":"Participants received single dose of 5mg Tirzepatide by subcutaneous injection."},{"id":"BG006","title":"Part A 8mg Tirzepatide","description":"Participants received single dose of 8mg Tirzepatide by subcutaneous injection."},{"id":"BG007","title":"Part B Placebo","description":"Participants received placebo by subcutaneous injection."},{"id":"BG008","title":"Part B 1.5mg 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(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"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"},{"groupId":"BG013","value":"10"},{"groupId":"BG014","value":"9"},{"groupId":"BG015","value":"8"},{"groupId":"BG016","value":"7"},{"groupId":"BG017","value":"12"},{"groupId":"BG018","value":"46"}]},{"title":"Not Hispanic or 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