{"protocolSection":{"identificationModule":{"nctId":"NCT04426474","orgStudyIdInfo":{"id":"17681"},"secondaryIdInfos":[{"id":"J2A-MC-GZGC","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2020-000125-86","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3502970 in Participants With Type 2 Diabetes","officialTitle":"A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-10-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-07-12","type":"ACTUAL"},"completionDateStruct":{"date":"2021-07-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-06-08","studyFirstSubmitQcDate":"2020-06-08","studyFirstPostDateStruct":{"date":"2020-06-11","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-26","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 learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":68,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY3502970","type":"EXPERIMENTAL","description":"3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally.","interventionNames":["Drug: LY3502970"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo administered orally.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["LY3502970"]},{"type":"DRUG","name":"Placebo","description":"Administered orally.","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","description":"An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.","timeFrame":"Baseline through Follow-up (up to Day 105)"}],"secondaryOutcomes":[{"measure":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970","description":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970","timeFrame":"Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose"},{"measure":"PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970","description":"PK: area under the concentration versus time curve from time 0 to 24 hours \\[AUC(0-24)\\] of LY3502970","timeFrame":"Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose"},{"measure":"Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)","description":"Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG).","timeFrame":"Baseline, Week 12"},{"measure":"PD: Change From Baseline to Week 12 in Fasting Insulin","description":"PD: Change From Baseline to Week 12 in Fasting Insulin.","timeFrame":"Baseline, Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (T2DM) for at least 6 months\n* Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening\n* Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive\n* Have had a stable body weight for the 3 months prior to screening (less than \\[\\<\\]5% body weight change)\n* Males and females (not considered woman of childbearing potential)\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening\n* Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure\n* Show evidence of hepatitis B, and/or positive hepatitis B surface antigen\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Any glucose-lowering medications other than metformin within 3 months prior to 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":"Clinical Pharmacology of Miami","city":"Hialeah","state":"Florida","zip":"33014","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"Hassman Research Institute","city":"Marlton","state":"New Jersey","zip":"08053","country":"United States","geoPoint":{"lat":39.89122,"lon":-74.92183}},{"facility":"Midwest Clinical Research Unit","city":"Dayton","state":"Ohio","zip":"45417","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"Endeavor Clinical Trials","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Profil Institut für Stoffwechselforschung","city":"Neuss","state":"North Rhine-Westphalia","zip":"41460","country":"Germany","geoPoint":{"lat":51.19807,"lon":6.68504}},{"facility":"Profil Mainz","city":"Mainz","zip":"55116","country":"Germany","geoPoint":{"lat":49.98185,"lon":8.28008}}]},"referencesModule":{"seeAlsoLinks":[{"label":"A Study of LY3502970 in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/7zwMq2LwDbIpQoxy04CHQ7"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks."},{"id":"FG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 milligrams (mg), 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"FG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"FG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"FG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"FG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"9"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"9"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"8"},{"groupId":"FG005","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"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 participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks."},{"id":"BG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"BG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"BG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"BG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"BG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"BG006","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"9"},{"groupId":"BG006","value":"68"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.0","spread":"6.0"},{"groupId":"BG001","value":"55.3","spread":"8.0"},{"groupId":"BG002","value":"57.7","spread":"6.4"},{"groupId":"BG003","value":"59.6","spread":"4.6"},{"groupId":"BG004","value":"58.8","spread":"4.6"},{"groupId":"BG005","value":"62.8","spread":"4.4"},{"groupId":"BG006","value":"57.9","spread":"6.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"26"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"42"}]}]}]},{"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":"8"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"30"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"38"}]},{"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":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"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":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"9"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"58"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"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":"10"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"40"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"28"}]}]}]}]},"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","description":"An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs 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 Follow-up (up to Day 105)","groups":[{"id":"OG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks."},{"id":"OG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970","description":"Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970","populationDescription":"All participants 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/milliliter (ng/mL)","timeFrame":"Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose","groups":[{"id":"OG000","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks"},{"id":"OG001","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks"},{"id":"OG002","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG003","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG004","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"101","spread":"28"},{"groupId":"OG001","value":"57.9","spread":"78"},{"groupId":"OG002","value":"97.9","spread":"30"},{"groupId":"OG003","value":"191","spread":"59"},{"groupId":"OG004","value":"218","spread":"40"}]}]}]},{"type":"SECONDARY","title":"PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970","description":"PK: area under the concentration versus time curve from time 0 to 24 hours \\[AUC(0-24)\\] of LY3502970","populationDescription":"All participants who received at least one dose of study drug and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms hour per milliliter (ng*h/mL)","timeFrame":"Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose","groups":[{"id":"OG000","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG001","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG002","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG003","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG004","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1480","spread":"23"},{"groupId":"OG001","value":"850","spread":"73"},{"groupId":"OG002","value":"1600","spread":"29"},{"groupId":"OG003","value":"3120","spread":"53"},{"groupId":"OG004","value":"3520","spread":"29"}]}]}]},{"type":"SECONDARY","title":"Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)","description":"Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG).","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least one post baseline FPG value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per litre (mmol/L)","timeFrame":"Baseline, Week 12","groups":[{"id":"OG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks."},{"id":"OG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.14","spread":"0.47"},{"groupId":"OG001","value":"-2.02","spread":"0.60"},{"groupId":"OG002","value":"-3.00","spread":"0.54"},{"groupId":"OG003","value":"-2.85","spread":"0.55"},{"groupId":"OG004","value":"-2.42","spread":"0.57"},{"groupId":"OG005","value":"-2.29","spread":"0.55"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Least Squares Mean Difference","paramValue":"-0.87","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.15","ciUpperLimit":"0.40"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Least Squares Mean Difference","paramValue":"-1.86","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.07","ciUpperLimit":"-0.65"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","statisticalMethod":"Least Squares Mean Difference","paramType":"Least Squares Mean Difference","paramValue":"-1.70","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.91","ciUpperLimit":"-0.50"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"SUPERIORITY","paramType":"Least Squares Mean Difference","paramValue":"-1.28","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.52","ciUpperLimit":"-0.03"},{"groupIds":["OG000","OG005"],"nonInferiorityType":"SUPERIORITY","paramType":"Least Squares Mean Difference","paramValue":"-1.14","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.35","ciUpperLimit":"0.07"}]},{"type":"SECONDARY","title":"PD: Change From Baseline to Week 12 in Fasting Insulin","description":"PD: Change From Baseline to Week 12 in Fasting Insulin.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least one post baseline fasting insulin value.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomoles/litre (pmol/L)","timeFrame":"Baseline, Week 12","groups":[{"id":"OG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks."},{"id":"OG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."},{"id":"OG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.71","spread":"11.14"},{"groupId":"OG001","value":"-12.20","spread":"13.13"},{"groupId":"OG002","value":"-5.46","spread":"14.48"},{"groupId":"OG003","value":"15.16","spread":"17.97"},{"groupId":"OG004","value":"7.30","spread":"17.09"},{"groupId":"OG005","value":"-1.32","spread":"15.63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in Estimated Mean Change","paramValue":"-2.50","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-30.82","ciUpperLimit":"25.83"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in Estimated Mean Change","paramValue":"4.24","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-25.81","ciUpperLimit":"34.30"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","paramType":"[Difference in Estimated Mean Change","paramValue":"24.87","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.91","ciUpperLimit":"59.65"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"SUPERIORITY","paramType":"[Difference in Estimated Mean Change","paramValue":"17.01","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.55","ciUpperLimit":"50.57"},{"groupIds":["OG000","OG005"],"nonInferiorityType":"SUPERIORITY","paramType":"[Difference in Estimated Mean Change","paramValue":"8.38","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-23.19","ciUpperLimit":"39.95"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline through Follow-up (up to Day 105)","description":"All participants who received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"Placebo QD","description":"Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":17,"seriousNumAffected":1,"seriousNumAtRisk":17,"otherNumAffected":7,"otherNumAtRisk":17},{"id":"EG001","title":"3/6/12/21 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":14,"seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":10,"otherNumAtRisk":14},{"id":"EG002","title":"3/6/9 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":8,"otherNumAtRisk":9},{"id":"EG003","title":"3/6/12/15 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":9,"otherNumAtRisk":10},{"id":"EG004","title":"3/6/12/21/27 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":8,"otherNumAtRisk":9},{"id":"EG005","title":"3/6/9/21/36/45 mg LY3502970 QD","description":"Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":9,"otherNumAtRisk":9}],"seriousEvents":[{"term":"Hand fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Skin laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Lung neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]}],"otherEvents":[{"term":"Bundle branch block left","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Ventricular extrasystoles","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":9}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Abdominal tenderness","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Breath odour","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG005","numEvents":3,"numAffected":3,"numAtRisk":9}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":10},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":9}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":14},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":9},{"groupId":"EG003","numEvents":8,"numAffected":5,"numAtRisk":10},{"groupId":"EG004","numEvents":4,"numAffected":3,"numAtRisk":9},{"groupId":"EG005","numEvents":12,"numAffected":7,"numAtRisk":9}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":4,"numAffected":2,"numAtRisk":14},{"groupId":"EG002","numEvents":23,"numAffected":5,"numAtRisk":9},{"groupId":"EG003","numEvents":11,"numAffected":5,"numAtRisk":10},{"groupId":"EG004","numEvents":12,"numAffected":5,"numAtRisk":9},{"groupId":"EG005","numEvents":24,"numAffected":5,"numAtRisk":9}]},{"term":"Chills","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Early satiety","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":9}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Vaccination site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Covid-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Fungal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Root canal infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Viral upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Eyelid injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Neck injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Vaccination complication","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Blood creatinine increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Blood urea increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Electrocardiogram pr prolongation","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Electrocardiogram qt prolonged","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":17},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":14},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":9},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":10},{"groupId":"EG004","numEvents":5,"numAffected":5,"numAtRisk":9},{"groupId":"EG005","numEvents":6,"numAffected":6,"numAtRisk":9}]},{"term":"Food aversion","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Rotator cuff syndrome","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Dizziness postural","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Drug withdrawal headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":9},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":9},{"groupId":"EG005","numEvents":3,"numAffected":2,"numAtRisk":9}]},{"term":"Lethargy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Listless","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Sleep disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]},{"term":"Skin ulcer","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":14},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":9}]}]},"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":"2021-01-28","uploadDate":"2022-06-29T16:58","filename":"Prot_000.pdf","size":6029140},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-08-07","uploadDate":"2022-06-29T16:59","filename":"SAP_001.pdf","size":3383513}]}},"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":"C000729680","term":"orforglipron"}]}},"hasResults":true}