{"protocolSection":{"identificationModule":{"nctId":"NCT04515576","orgStudyIdInfo":{"id":"17530"},"secondaryIdInfos":[{"id":"J1X-MC-GZHC","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3493269 in Participants With Type 2 Diabetes","officialTitle":"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Subcutaneous Doses of LY3493269 in Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2024-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-08-25","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-03-09","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-09","type":"ACTUAL"},"studyFirstSubmitDate":"2020-08-14","studyFirstSubmitQcDate":"2020-08-14","studyFirstPostDateStruct":{"date":"2020-08-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-12-04","resultsFirstSubmitQcDate":"2024-12-04","resultsFirstPostDateStruct":{"date":"2025-01-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-12-04","lastUpdatePostDateStruct":{"date":"2025-01-14","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 is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":56,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1.5 milligrams (mg) Dulaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.","interventionNames":["Drug: Dulaglutide"]},{"label":"0.3 mg LY3493269","type":"EXPERIMENTAL","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.","interventionNames":["Drug: LY3493269"]},{"label":"1 mg LY3493269","type":"EXPERIMENTAL","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.","interventionNames":["Drug: LY3493269"]},{"label":"0.75/1.5/3 mg LY3493269","type":"EXPERIMENTAL","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.","interventionNames":["Drug: LY3493269"]},{"label":"1.5/3/4/5 mg LY3493269","type":"EXPERIMENTAL","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.","interventionNames":["Drug: LY3493269"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY3493269","description":"Administered SC","armGroupLabels":["0.3 mg LY3493269","0.75/1.5/3 mg LY3493269","1 mg LY3493269","1.5/3/4/5 mg LY3493269"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["1.5 milligrams (mg) Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment.\n\nAn SAE is defined as any untoward medical occurrence that, at any dose:\n\n1. Results in death\n2. Is life-threatening\n3. Requires inpatient hospitalization or prolongation of existing hospitalization\n4. Results in persistent disability/incapacity\n5. Is a congenital anomaly/birth defect\n6. Other situations: Based on medical or scientific judgement.\n\nA summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","timeFrame":"Baseline through final follow-up at Day 57"}],"secondaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269","description":"Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269","timeFrame":"Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4."},{"measure":"PK: Maximum Observed Drug Concentration (Cmax) of LY3493269","description":"Maximum Observed Drug Concentration (Cmax) of LY3493269","timeFrame":"Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4."},{"measure":"Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose","description":"Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.","timeFrame":"Baseline, Day 29"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Are male or female not of childbearing potential\n* Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening\n* Have had a stable body weight (\\<5% body weight change) for the 3 months prior to screening\n* Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening\n* Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening\n* Have an HbA1c of at least 7.0% and no more than 10.5% at screening\n* Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults\n* Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening\n* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment\n* Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea\n* Have a history of acute or chronic pancreatitis\n* Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma\n* Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening","healthyVolunteers":false,"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":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Miami Research Associates","city":"Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Clinical Trials of Texas, Inc.","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}}]},"referencesModule":{"seeAlsoLinks":[{"label":"A Study of LY3493269 in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/1xujziv0yfFVul40lqzrPv"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks."},{"id":"FG001","title":"1.5 Milligrams (mg) Dulaglutide","description":"Participants received 1.5 mg dulaglutide SC QW for 4 weeks."},{"id":"FG002","title":"0.3 mg LY3493269","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"FG003","title":"1 mg LY3493269","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks."},{"id":"FG004","title":"0.75/1.5/3 mg LY3493269","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"FG005","title":"1.5/3/4/5 mg LY3493269","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"14"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"14"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"13"}]},{"type":"NOT 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":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks."},{"id":"BG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide SC QW for 4 weeks."},{"id":"BG002","title":"0.3 mg LY3493269","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"BG003","title":"1 mg LY3493269","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks"},{"id":"BG004","title":"0.75/1.5/3 mg LY3493269","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"BG005","title":"1.5/3/4/5 mg LY3493269","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."},{"id":"BG006","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"11"},{"groupId":"BG005","value":"14"},{"groupId":"BG006","value":"56"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.9","spread":"6.7"},{"groupId":"BG001","value":"63.3","spread":"6.6"},{"groupId":"BG002","value":"60.9","spread":"5.6"},{"groupId":"BG003","value":"59.8","spread":"3.4"},{"groupId":"BG004","value":"55.1","spread":"5.3"},{"groupId":"BG005","value":"59.9","spread":"6.9"},{"groupId":"BG006","value":"59.2","spread":"6.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"25"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"31"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"13"},{"groupId":"BG006","value":"46"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"10"}]},{"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":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"}]},{"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":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"4"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"13"},{"groupId":"BG006","value":"50"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"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":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"11"},{"groupId":"BG005","value":"14"},{"groupId":"BG006","value":"56"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","description":"TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment.\n\nAn SAE is defined as any untoward medical occurrence that, at any dose:\n\n1. Results in death\n2. Is life-threatening\n3. Requires inpatient hospitalization or prolongation of existing hospitalization\n4. Results in persistent disability/incapacity\n5. Is a congenital anomaly/birth defect\n6. Other situations: Based on medical or scientific judgement.\n\nA summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","populationDescription":"All participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline through final follow-up at Day 57","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide SC QW for 4 weeks."},{"id":"OG002","title":"0.3 mg LY3493269","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"OG003","title":"1 mg LY3493269","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks."},{"id":"OG004","title":"0.75/1.5/3 mg LY3493269","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"OG005","title":"1.5/3/4/5 mg LY3493269","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"14"}]}],"classes":[{"title":"SAEs Related to Study Drug Administration","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"TEAEs Related to Study Drug Administration","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"13"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269","description":"Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269","populationDescription":"All participants who received at least one dose of LY3493269 and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.","groups":[{"id":"OG000","title":"0.3 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"OG001","title":"1 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks."},{"id":"OG002","title":"0.75/1.5/3 mg LY3493269 QW","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"OG003","title":"1.5/3/4/5 mg LY3493269 QW","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"11"}]}],"classes":[{"title":"Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4220","spread":"27"},{"groupId":"OG001","value":"18500","spread":"40"},{"groupId":"OG002","value":"10200","spread":"30"},{"groupId":"OG003","value":"22800","spread":"25"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10600","spread":"21"},{"groupId":"OG001","value":"38500","spread":"25"},{"groupId":"OG002","value":"105000","spread":"27"},{"groupId":"OG003","value":"123000","spread":"22"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Observed Drug Concentration (Cmax) of LY3493269","description":"Maximum Observed Drug Concentration (Cmax) of LY3493269","populationDescription":"All participants who received at least one dose of LY3493269 and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter (ng/mL)","timeFrame":"Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.","groups":[{"id":"OG000","title":"0.3 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"OG001","title":"1 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks."},{"id":"OG002","title":"0.75/1.5/3 mg LY3493269 QW","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"OG003","title":"1.5/3/4/5 mg LY3493269 QW","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"14"}]}],"classes":[{"title":"Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"31.2","spread":"31"},{"groupId":"OG001","value":"153","spread":"51"},{"groupId":"OG002","value":"73.6","spread":"32"},{"groupId":"OG003","value":"165","spread":"34"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"80.3","spread":"22"},{"groupId":"OG001","value":"287","spread":"26"},{"groupId":"OG002","value":"818","spread":"28"},{"groupId":"OG003","value":"920","spread":"28"}]}]}]},{"type":"SECONDARY","title":"Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose","description":"Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.","populationDescription":"All participants who received at least one dose of study drug and had evaluable fasting plasma glucose data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per litre (mmol/L)","timeFrame":"Baseline, Day 29","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks."},{"id":"OG001","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg dulaglutide SC QW for 4 weeks."},{"id":"OG002","title":"0.3 mg LY3493269","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks."},{"id":"OG003","title":"1 mg LY3493269","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks."},{"id":"OG004","title":"0.75/1.5/3 mg LY3493269","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses."},{"id":"OG005","title":"1.5/3/4/5 mg LY3493269","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"2.34"},{"groupId":"OG001","value":"-4.11","spread":"2.82"},{"groupId":"OG002","value":"-2.20","spread":"1.47"},{"groupId":"OG003","value":"-4.83","spread":"2.75"},{"groupId":"OG004","value":"-3.61","spread":"3.29"},{"groupId":"OG005","value":"-3.98","spread":"3.11"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline through final follow-up at Day 57","description":"All participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.","deathsNumAffected":0,"deathsNumAtRisk":7,"seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":2,"otherNumAtRisk":7},{"id":"EG001","title":"1.5 mg Dulaglutide QW","description":"Participants received 1.5 mg dulaglutide SC QW for 4 weeks.","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":5,"otherNumAtRisk":8},{"id":"EG002","title":"0.3 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":5,"otherNumAtRisk":8},{"id":"EG003","title":"1 mg LY3493269 QW","description":"Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":7,"otherNumAtRisk":8},{"id":"EG004","title":"0.75/1.5/3 mg LY3493269 QW","description":"Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":11,"otherNumAtRisk":11},{"id":"EG005","title":"1.5/3/4/5 mg LY3493269 QW","description":"Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.","deathsNumAffected":0,"deathsNumAtRisk":14,"seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":13,"otherNumAtRisk":14}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":14}]},{"term":"Vision blurred","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":8,"numAffected":6,"numAtRisk":8},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":11},{"groupId":"EG005","numEvents":5,"numAffected":4,"numAtRisk":14}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":3,"numAffected":2,"numAtRisk":14}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":14}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":2,"numAffected":1,"numAtRisk":14}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":6,"numAffected":4,"numAtRisk":11},{"groupId":"EG005","numEvents":5,"numAffected":5,"numAtRisk":14}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":15,"numAffected":7,"numAtRisk":8},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":11},{"groupId":"EG005","numEvents":5,"numAffected":4,"numAtRisk":14}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":6,"numAffected":4,"numAtRisk":8},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":11},{"groupId":"EG005","numEvents":9,"numAffected":5,"numAtRisk":14}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":9,"numAffected":3,"numAtRisk":14}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":4,"numAffected":4,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Injection site haemorrhage","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Medical device site dermatitis","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":4,"numAffected":2,"numAtRisk":14}]},{"term":"Tenderness","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":2,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Vessel puncture site haemorrhage","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Arthropod bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Epicondylitis","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Procedural nausea","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":8},{"groupId":"EG004","numEvents":4,"numAffected":3,"numAtRisk":11},{"groupId":"EG005","numEvents":8,"numAffected":8,"numAtRisk":14}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":8},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":2,"numAffected":1,"numAtRisk":14}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":2,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":6,"numAffected":5,"numAtRisk":11},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":14}]},{"term":"Paraesthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Hiccups","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Sensitive skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":4,"numAffected":4,"numAtRisk":14}]},{"term":"Skin burning sensation","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":8},{"groupId":"EG004","numEvents":7,"numAffected":7,"numAtRisk":11},{"groupId":"EG005","numEvents":8,"numAffected":7,"numAtRisk":14}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":14}]},{"term":"Withdrawal hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":7},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":8},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":8},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":14}]}]},"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":"2021-07-16","uploadDate":"2022-08-04T16:29","filename":"Prot_000.pdf","size":6456862},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-08-03","uploadDate":"2022-08-04T16:30","filename":"SAP_001.pdf","size":4176140}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C555680","term":"dulaglutide"}]}},"hasResults":true}