{"protocolSection":{"identificationModule":{"nctId":"NCT06010004","orgStudyIdInfo":{"id":"18745"},"secondaryIdInfos":[{"id":"J2A-JE-GZPE","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes","officialTitle":"A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)","acronym":"ACHIEVE-J"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-09-28","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-06-05","type":"ACTUAL"},"completionDateStruct":{"date":"2025-06-05","type":"ACTUAL"},"studyFirstSubmitDate":"2023-08-21","studyFirstSubmitQcDate":"2023-08-21","studyFirstPostDateStruct":{"date":"2023-08-24","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-06-04","resultsFirstSubmitQcDate":"2026-06-04","resultsFirstPostDateStruct":{"date":"2026-06-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-04","lastUpdatePostDateStruct":{"date":"2026-06-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.\n\nThis study includes 3 periods as follows:\n\n* screening and lead-in period: up to 4 weeks\n* treatment period: 52 weeks, including 20 weeks of dose escalation, and\n* safety follow-up period: 2 weeks."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":401,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"3 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.","interventionNames":["Drug: Orforglipron"]},{"label":"12 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.","interventionNames":["Drug: Orforglipron"]},{"label":"36 mg Orforglipron","type":"EXPERIMENTAL","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.","interventionNames":["Drug: Orforglipron"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally","armGroupLabels":["12 mg Orforglipron","3 mg Orforglipron","36 mg Orforglipron"],"otherNames":["LY3502970"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.","timeFrame":"Baseline to Week 54"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c <7.0%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c ≤6.5%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Percentage of Participants Who Achieved HbA1c <5.7%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Fasting Serum Glucose","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Weight","timeFrame":"Baseline, Week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","timeFrame":"Week 52"},{"measure":"Change From Baseline in Waist Circumference","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Body Mass Index (BMI)","timeFrame":"Baseline, Week 52"},{"measure":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)","description":"SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day:\n\n* before 3 main meals,\n* approximately 2 hours after 3 main meals, and\n* at bedtime\n\nDaily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.","timeFrame":"Baseline, Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have Type 2 Diabetes (T2D)\n* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.\n* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.\n* Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes (T1D).\n* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.\n* Have New York Heart Association functional classification IV congestive heart failure.\n* Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke), or\n  * hospitalization for congestive heart failure\n* Have acute or chronic hepatitis and pancreatitis","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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":"Nakayama Clinic","city":"Nagoya","state":"Aichi-ken","zip":"456-0058","country":"Japan","geoPoint":{"lat":35.18147,"lon":136.90641}},{"facility":"Shinkashiwa Clinic","city":"Kashiwa","state":"Chiba","zip":"277-0084","country":"Japan","geoPoint":{"lat":35.86224,"lon":139.97732}},{"facility":"Kashiwa City Hospital","city":"Kashiwa","state":"Chiba","zip":"277-0825","country":"Japan","geoPoint":{"lat":35.86224,"lon":139.97732}},{"facility":"Tokuyama Clinic","city":"Mihama-ku,Chiba City","state":"Chiba","zip":"261-0004","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Mikannohana Clinic, Diabetes, Endocrinology and Metabolism","city":"Matsuyama","state":"Ehime","zip":"790-0034","country":"Japan","geoPoint":{"lat":33.83916,"lon":132.76574}},{"facility":"Steel Memorial Yawata Hospital","city":"Kitakyushu","state":"Fukuoka","zip":"805-8508","country":"Japan","geoPoint":{"lat":33.85181,"lon":130.85034}},{"facility":"Hasegawa Medical Clinic","city":"Chitose","state":"Hokkaido","zip":"066-0032","country":"Japan","geoPoint":{"lat":42.81944,"lon":141.65222}},{"facility":"Odori Diabetes","city":"Sapporo","state":"Hokkaido","zip":"060-0001","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Matsuda Clinic","city":"Kobe","state":"Hyōgo","zip":"651-2135","country":"Japan","geoPoint":{"lat":34.6913,"lon":135.183}},{"facility":"Nakamoto Internal Medicine Clinic","city":"Mito","state":"Ibaraki","zip":"310-0826","country":"Japan","geoPoint":{"lat":36.35,"lon":140.45}},{"facility":"MinamiAkatsukaClinic","city":"Mito","state":"Ibaraki","zip":"311-4153","country":"Japan","geoPoint":{"lat":36.35,"lon":140.45}},{"facility":"Nakakinen clinic","city":"Naka","state":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":36.05,"lon":140.16667}},{"facility":"Nishiyamadou Keiwa Hospital","city":"Naka","state":"Ibaraki","zip":"311-0133","country":"Japan","geoPoint":{"lat":36.05,"lon":140.16667}},{"facility":"Taya Clinic Koueikai Medical Corporation","city":"Tsuchiura","state":"Ibaraki","zip":"300-0047","country":"Japan","geoPoint":{"lat":36.09047,"lon":140.21047}},{"facility":"Shonan Takai Clinic","city":"Kamakura","state":"Kanagawa","zip":"247-0055","country":"Japan","geoPoint":{"lat":35.31085,"lon":139.54698}},{"facility":"Takai Internal Medicine Clinic","city":"Kamakura-shi","state":"Kanagawa","zip":"247-0056","country":"Japan"},{"facility":"Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic","city":"Yamato-shi","state":"Kanagawa","zip":"242-0004","country":"Japan"},{"facility":"Yokohama Minoru Clinic","city":"Yokohama","state":"Kanagawa","zip":"232-0064","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"Yokkaichi Diabetes Clinic","city":"Yokkaichi","state":"Mie-ken","zip":"510-0829","country":"Japan","geoPoint":{"lat":34.96667,"lon":136.61667}},{"facility":"Gibo Hepatology Clinic","city":"Matsumoto","state":"Nagano","zip":"399-0036","country":"Japan","geoPoint":{"lat":36.23333,"lon":137.96667}},{"facility":"Shiraiwa Medical Clinic","city":"Kashihara","state":"Osaka","zip":"582-0005","country":"Japan","geoPoint":{"lat":34.58333,"lon":135.61667}},{"facility":"Kitada Clinic","city":"Osaka","state":"Osaka","zip":"538-0044","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Medical Corporation Heishinkai OCROM Clinic","city":"Suita-shi","state":"Osaka","zip":"565-0853","country":"Japan"},{"facility":"OHAMA Diabetes Clinic","city":"Kawaguchi","state":"Saitama","zip":"332-0015","country":"Japan","geoPoint":{"lat":35.80521,"lon":139.71072}},{"facility":"Sugiura Internal Medicine Clinic","city":"Sōka","state":"Saitama","zip":"340-0015","country":"Japan","geoPoint":{"lat":35.83643,"lon":139.79957}},{"facility":"Seiwa Clinic","city":"Adachi-ku","state":"Tokyo","zip":"120-0011","country":"Japan"},{"facility":"The Institute for Adult Disease, Asahi Life Foundation","city":"Chuo-ku","state":"Tokyo","zip":"103-0002","country":"Japan"},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104-0031","country":"Japan"},{"facility":"Hachioji Diabetes Clinic","city":"Hachioji-shi","state":"Tokyo","zip":"192-0083","country":"Japan"},{"facility":"Kanno Naika","city":"Mitaka","state":"Tokyo","zip":"181-0013","country":"Japan","geoPoint":{"lat":35.68361,"lon":139.56002}},{"facility":"Heishinkai Medical Group ToCROM Clinic","city":"Shinjuku-ku","state":"Tokyo","zip":"160-0008","country":"Japan"},{"facility":"Medical Corporation Tao Internal Medicine Clinic","city":"Ube","state":"Yamaguchi","zip":"755-0047","country":"Japan","geoPoint":{"lat":33.94306,"lon":131.25111}},{"facility":"Fujii Clinic","city":"Ube","state":"Yamaguchi","zip":"755-0049","country":"Japan","geoPoint":{"lat":33.94306,"lon":131.25111}},{"facility":"Tashiro Endocrinology Clinic","city":"Fukuoka","zip":"814-0153","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Morinaga Ueno Clinic","city":"Kumamoto","zip":"860-0863","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Jinnouchi Hospital","city":"Kumamoto","zip":"862-0976","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Heiwadai Hospital","city":"Miyazaki","zip":"880-0034","country":"Japan","geoPoint":{"lat":31.91667,"lon":131.41667}},{"facility":"Kansai Electric Power Hospital","city":"Osaka","zip":"553-0003","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Abe Clinic","city":"Ōita","zip":"870-0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}}]},"referencesModule":{"references":[{"pmid":"42607698","type":"DERIVED","citation":"Yabe D, Shiraiwa T, Ugai H, Takeuchi M, Suzuki R. Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial. Lancet Diabetes Endocrinol. 2026 Aug 17:S2213-8587(26)00138-5. doi: 10.1016/S2213-8587(26)00138-5. Online ahead of print."}],"seeAlsoLinks":[{"label":"A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)","url":"https://trials.lilly.com/en-US/trial/419717"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"FG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"FG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"135"},{"groupId":"FG002","numSubjects":"134"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"135"},{"groupId":"FG002","numSubjects":"134"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"125"},{"groupId":"FG001","numSubjects":"128"},{"groupId":"FG002","numSubjects":"125"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"9"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who were randomized and received at least one dose of the study drug.","groups":[{"id":"BG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"BG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"BG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"134"},{"groupId":"BG003","value":"401"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.9","spread":"10.3"},{"groupId":"BG001","value":"58.5","spread":"11.0"},{"groupId":"BG002","value":"57.5","spread":"10.7"},{"groupId":"BG003","value":"58.6","spread":"10.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"41"},{"groupId":"BG003","value":"118"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"93"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"283"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"134"},{"groupId":"BG003","value":"401"}]}]}]},{"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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"134"},{"groupId":"BG003","value":"401"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"134"},{"groupId":"BG003","value":"401"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.","populationDescription":"All participants who were randomized and received at least one dose of the study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline to Week 54","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"135"},{"groupId":"OG002","value":"134"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"118"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.","populationDescription":"All participants who were randomized and had non-missing HbA1c values at baseline and week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.71","spread":"0.072"},{"groupId":"OG001","value":"-1.97","spread":"0.075"},{"groupId":"OG002","value":"-2.13","spread":"0.073"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c <7.0%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing HbA1c values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82.73","spread":"3.25"},{"groupId":"OG001","value":"86.11","spread":"2.86"},{"groupId":"OG002","value":"90.82","spread":"2.52"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c ≤6.5%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing HbA1c values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"62.64","spread":"4.11"},{"groupId":"OG001","value":"76.23","spread":"3.57"},{"groupId":"OG002","value":"84.56","spread":"3.27"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1c <5.7%","description":"HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing HbA1c values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.70","spread":"2.20"},{"groupId":"OG001","value":"21.92","spread":"3.54"},{"groupId":"OG002","value":"30.51","spread":"3.86"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","populationDescription":"All participants who were randomized and had non-missing fasting serum glucose values at baseline and week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"128"},{"groupId":"OG002","value":"124"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-51.7","spread":"1.40"},{"groupId":"OG001","value":"-55.1","spread":"2.86"},{"groupId":"OG002","value":"-64.5","spread":"1.37"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","populationDescription":"All participants who were randomized and had non-missing body weight values at baseline and week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.81","spread":"0.307"},{"groupId":"OG001","value":"-5.08","spread":"0.474"},{"groupId":"OG002","value":"-6.75","spread":"0.509"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing body weight values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.00","spread":"3.90"},{"groupId":"OG001","value":"49.52","spread":"4.40"},{"groupId":"OG002","value":"65.14","spread":"4.24"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing body weight values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.11","spread":"2.66"},{"groupId":"OG001","value":"24.68","spread":"3.78"},{"groupId":"OG002","value":"37.91","spread":"4.30"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline","description":"The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.","populationDescription":"All participants who were randomized and had non-missing body weight values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.79","spread":"1.46"},{"groupId":"OG001","value":"13.96","spread":"3.07"},{"groupId":"OG002","value":"20.94","spread":"3.66"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference","populationDescription":"All participants who were randomized and had non-missing waist circumference values at baseline and week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"centimeter (cm)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"110"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.4","spread":"0.43"},{"groupId":"OG001","value":"-4.6","spread":"0.49"},{"groupId":"OG002","value":"-6.5","spread":"0.54"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI)","populationDescription":"All participants who were randomized and had non-missing BMI values at baseline and week 52.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"110"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"0.12"},{"groupId":"OG001","value":"-1.9","spread":"0.17"},{"groupId":"OG002","value":"-2.5","spread":"0.19"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)","description":"SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day:\n\n* before 3 main meals,\n* approximately 2 hours after 3 main meals, and\n* at bedtime\n\nDaily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.","populationDescription":"All participants who were randomized and had non-missing 7-Point SMBG values at baseline and week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration."},{"id":"OG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration."},{"id":"OG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"126"},{"groupId":"OG002","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-66.32","spread":"40.622"},{"groupId":"OG001","value":"-73.14","spread":"41.064"},{"groupId":"OG002","value":"-82.27","spread":"39.367"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to Week 54","description":"* All participants who were randomized and received at least one dose of the study drug.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.\n* All the adverse events were recorded as per the planned treatment regimen.","eventGroups":[{"id":"EG000","title":"3 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.","deathsNumAffected":0,"deathsNumAtRisk":132,"seriousNumAffected":4,"seriousNumAtRisk":132,"otherNumAffected":106,"otherNumAtRisk":132},{"id":"EG001","title":"12 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.","deathsNumAffected":0,"deathsNumAtRisk":135,"seriousNumAffected":3,"seriousNumAtRisk":135,"otherNumAffected":114,"otherNumAtRisk":135},{"id":"EG002","title":"36 mg Orforglipron","description":"Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.","deathsNumAffected":1,"deathsNumAtRisk":134,"seriousNumAffected":6,"seriousNumAtRisk":134,"otherNumAffected":118,"otherNumAtRisk":134}],"seriousEvents":[{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":134}]},{"term":"Periodontitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Humerus fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":134}]},{"term":"Lumbar vertebral fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":134}]},{"term":"Spinal osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Lipoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":93},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":97},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":93}]},{"term":"Persistent depressive disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":134}]},{"term":"Aortic stenosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Iron deficiency anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":134}]},{"term":"Arrhythmia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":132},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":135},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":134}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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