{"protocolSection":{"identificationModule":{"nctId":"NCT05872620","orgStudyIdInfo":{"id":"18560"},"secondaryIdInfos":[{"id":"J2A-MC-GZGQ","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2022-502837-24-00","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"U1111-1289-8799","type":"OTHER","domain":"UTN Number"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes","officialTitle":"A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)","acronym":"ATTAIN-2"},"statusModule":{"statusVerifiedDate":"2026-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-06-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-08-08","type":"ACTUAL"},"completionDateStruct":{"date":"2025-08-08","type":"ACTUAL"},"studyFirstSubmitDate":"2023-05-15","studyFirstSubmitQcDate":"2023-05-15","studyFirstPostDateStruct":{"date":"2023-05-24","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-08-07","resultsFirstSubmitQcDate":"2026-09-03","resultsFirstPostDateStruct":{"date":"2026-09-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-09-03","lastUpdatePostDateStruct":{"date":"2026-09-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits."},"conditionsModule":{"conditions":["Obesity","Overweight","Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":1613,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.","interventionNames":["Drug: Placebo"]},{"label":"6 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.","interventionNames":["Drug: Orforglipron"]},{"label":"12 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.","interventionNames":["Drug: Orforglipron"]},{"label":"36 mg Orforglipron QD","type":"EXPERIMENTAL","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.","interventionNames":["Drug: Orforglipron"]}],"interventions":[{"type":"DRUG","name":"Orforglipron","description":"Administered orally","armGroupLabels":["12 mg Orforglipron QD","36 mg Orforglipron QD","6 mg Orforglipron QD"],"otherNames":["LY3502970"]},{"type":"DRUG","name":"Placebo","description":"Administered orally","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","timeFrame":"Baseline to Week 72"},{"measure":"Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","timeFrame":"Baseline to Week 72"},{"measure":"Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","timeFrame":"Baseline to Week 72"},{"measure":"Change From Baseline in Waist Circumference","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) %","description":"* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.\n* Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)","description":"Percentage of participants who achieved hemoglobin A1c (HbA1c\\<6.5%) was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","timeFrame":"Baseline to Week 72"},{"measure":"Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)","description":"Percentage of participants who achieved hemoglobin A1c (HbA1c\\<7%) was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","timeFrame":"Baseline to Week 72"},{"measure":"Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Fasting Insulin","description":"* Fasting Insulin is a test used to measure the amount of insulin in the body.\n* Values represented under \"Geometric Least Squares Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under \"Geometric Least Squares Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under \"Geometric Least Square Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","timeFrame":"Baseline, Week 72"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n* Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:\n\n  * either diet/exercise alone or\n  * up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.\n* Have a self-reported change in body weight \\>5 kg (11 pounds) within 90 days prior to screening.\n* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).\n* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.\n* Have had a history of chronic or acute 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":"Cahaba Research - Pelham","city":"Pelham","state":"Alabama","zip":"35124","country":"United States","geoPoint":{"lat":33.28567,"lon":-86.80999}},{"facility":"Novak Clinical Research - Tucson - North La Cholla Boulevard","city":"Tucson","state":"Arizona","zip":"85741","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Yuma Clinical Trials","city":"Yuma","state":"Arizona","zip":"85364","country":"United States","geoPoint":{"lat":32.72532,"lon":-114.6244}},{"facility":"AMCR Institute","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Velocity Clinical Research, Huntington Park","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"Velocity Clinical Research, Westlake","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","zip":"91763","country":"United States","geoPoint":{"lat":34.07751,"lon":-117.68978}},{"facility":"University Clinical Investigators, Inc.","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"Encore Medical Research","city":"Hollywood","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"East Coast Institute for Research, LLC","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"South Florida Clinical Research Institute","city":"Margate","state":"Florida","zip":"33063","country":"United States","geoPoint":{"lat":26.24453,"lon":-80.20644}},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Balanced Life Health Care Solutions/SKYCRNG","city":"Lawrenceville","state":"Georgia","zip":"30046","country":"United States","geoPoint":{"lat":33.95621,"lon":-83.98796}},{"facility":"Endocrine Research Solutions, Inc.","city":"Roswell","state":"Georgia","zip":"30076","country":"United States","geoPoint":{"lat":34.02316,"lon":-84.36159}},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","zip":"30189","country":"United States","geoPoint":{"lat":34.10149,"lon":-84.51938}},{"facility":"Pacific Diabetes & Endocrine Center","city":"Honolulu","state":"Hawaii","zip":"96813","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Solaris Clinical Research","city":"Meridian","state":"Idaho","zip":"83646","country":"United States","geoPoint":{"lat":43.61211,"lon":-116.39151}},{"facility":"Iowa Diabetes and Endocrinology Research Center","city":"West Des Moines","state":"Iowa","zip":"50265","country":"United States","geoPoint":{"lat":41.57721,"lon":-93.71133}},{"facility":"MedStar Good Samaritan Hospital","city":"Baltimore","state":"Maryland","zip":"21239","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Arcturus Healthcare , PLC, Troy Internal Medicine Research Division","city":"Troy","state":"Michigan","zip":"48098","country":"United States","geoPoint":{"lat":42.60559,"lon":-83.14993}},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","zip":"63303","country":"United States","geoPoint":{"lat":38.80033,"lon":-90.62651}},{"facility":"Las Vegas Medical Research","city":"Las Vegas","state":"Nevada","zip":"89128","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"IMA Clinical Research","city":"Albuquerque","state":"New Mexico","zip":"87109","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"Albany Medical College, Division of Community Endocrinology","city":"Albany","state":"New York","zip":"12203","country":"United States","geoPoint":{"lat":42.65258,"lon":-73.75623}},{"facility":"Albany Stratton VA Medical Center","city":"Albany","state":"New York","zip":"12208","country":"United States","geoPoint":{"lat":42.65258,"lon":-73.75623}},{"facility":"NYC Research INC","city":"Long Island City","state":"New York","zip":"11106","country":"United States","geoPoint":{"lat":40.74482,"lon":-73.94875}},{"facility":"Accellacare - 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Orforglipron for obesity treatment in older patients >/=65 years with or without type 2 diabetes: A post hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials. Obes Pillars. 2026 Jul 14;19:100301. doi: 10.1016/j.obpill.2026.100301. eCollection 2026 Sep."},{"pmid":"41275875","type":"DERIVED","citation":"Horn DB, Ryan DH, Kis SG, Alves B, Mu Y, Kim SG, Aberle J, Bain SC, Allen S, Sarker E, Wu Q, Stefanski A, Jouravskaya I; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2026 Dec 20;406(10522):2927-2944. doi: 10.1016/S0140-6736(25)02165-8. Epub 2025 Nov 20."}],"seeAlsoLinks":[{"label":"A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)","url":"https://trials.lilly.com/en-US/trial/404300"}]},"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":"Time Frame:\n\nData are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. 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All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. 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Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.21","spread":"0.215"},{"groupId":"OG001","value":"-5.50","spread":"0.356"},{"groupId":"OG002","value":"-7.78","spread":"0.411"},{"groupId":"OG003","value":"-10.54","spread":"0.466"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.10","ciUpperLimit":"-2.47"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.48","ciUpperLimit":"-4.65"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-8.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.34","ciUpperLimit":"-7.32"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.4"},{"groupId":"OG001","value":"49.8"},{"groupId":"OG002","value":"60.2"},{"groupId":"OG003","value":"72.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"25.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.54","ciUpperLimit":"32.31"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"35.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"29.12","ciUpperLimit":"42.45"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"48.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"41.95","ciUpperLimit":"54.80"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.0"},{"groupId":"OG001","value":"23.9"},{"groupId":"OG002","value":"35.5"},{"groupId":"OG003","value":"50.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"16.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.53","ciUpperLimit":"22.31"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"28.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"22.69","ciUpperLimit":"34.31"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"43.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"36.86","ciUpperLimit":"49.45"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline","description":"Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.9"},{"groupId":"OG001","value":"7.3"},{"groupId":"OG002","value":"17.7"},{"groupId":"OG003","value":"28.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"5.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.25","ciUpperLimit":"8.59"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"15.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.32","ciUpperLimit":"20.24"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"26.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"21.27","ciUpperLimit":"31.76"}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"centimeters","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.67","spread":"0.233"},{"groupId":"OG001","value":"-5.64","spread":"0.394"},{"groupId":"OG002","value":"-7.16","spread":"0.422"},{"groupId":"OG003","value":"-9.16","spread":"0.437"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-2.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.87","ciUpperLimit":"-2.07"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-4.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.44","ciUpperLimit":"-3.54"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.46","ciUpperLimit":"-5.51"}]},{"type":"SECONDARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c) %","description":"* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.\n* Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.14","spread":"0.060"},{"groupId":"OG001","value":"-1.29","spread":"0.069"},{"groupId":"OG002","value":"-1.60","spread":"0.058"},{"groupId":"OG003","value":"-1.79","spread":"0.059"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.34","ciUpperLimit":"-0.98"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.62","ciUpperLimit":"-1.30"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-1.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.82","ciUpperLimit":"-1.49"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose (FSG)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"1.90"},{"groupId":"OG001","value":"-33.0","spread":"2.13"},{"groupId":"OG002","value":"-41.1","spread":"1.69"},{"groupId":"OG003","value":"-45.8","spread":"1.79"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-34.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-39.8","ciUpperLimit":"-28.6"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-42.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-47.3","ciUpperLimit":"-37.3"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-47.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-52.1","ciUpperLimit":"-41.9"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)","description":"Percentage of participants who achieved hemoglobin A1c (HbA1c\\<6.5%) was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.6"},{"groupId":"OG001","value":"56.2"},{"groupId":"OG002","value":"67.5"},{"groupId":"OG003","value":"75.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"45.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"39.29","ciUpperLimit":"51.89"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"56.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"50.83","ciUpperLimit":"63.01"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"64.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"58.67","ciUpperLimit":"70.18"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)","description":"Percentage of participants who achieved hemoglobin A1c (HbA1c\\<7%) was analysed by Logistic regression with the following variables: region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"322"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.0"},{"groupId":"OG001","value":"70.0"},{"groupId":"OG002","value":"78.0"},{"groupId":"OG003","value":"85.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"46.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"40.48","ciUpperLimit":"53.49"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"55.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"48.89","ciUpperLimit":"61.25"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"62.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"56.51","ciUpperLimit":"67.64"}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"Pooled 6 mg/12 mg/36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, 12 mg and 36 mg, which was maintained through Week 72, unless dose modification was required. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"983"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.48","spread":"0.534"},{"groupId":"OG001","value":"-4.90","spread":"0.414"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-3.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.75","ciUpperLimit":"-2.10"}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.","populationDescription":"All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"Pooled 6 mg/12 mg/36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, 12 mg and 36 mg, which was maintained through Week 72, unless dose modification was required. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"983"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.39","spread":"0.323"},{"groupId":"OG001","value":"-1.32","spread":"0.261"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.869","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"0.88"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Fasting Insulin","description":"* Fasting Insulin is a test used to measure the amount of insulin in the body.\n* Values represented under \"Geometric Least Squares Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"6 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG002","title":"12 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required."},{"id":"OG003","title":"36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"609"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"321"},{"groupId":"OG003","value":"313"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.8","spread":"2.54"},{"groupId":"OG001","value":"-6.4","spread":"2.89"},{"groupId":"OG002","value":"-8.3","spread":"3.18"},{"groupId":"OG003","value":"-18.0","spread":"2.91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.530","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.4","ciUpperLimit":"11.4"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.898","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.8","ciUpperLimit":"9.7"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.019","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-10.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.7","ciUpperLimit":"-1.7"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under \"Geometric Least Squares Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"Pooled 6 mg/12 mg/36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, 12 mg and 36 mg, which was maintained through Week 72, unless dose modification was required. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"607"},{"groupId":"OG001","value":"952"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.95","spread":"1.182"},{"groupId":"OG001","value":"-6.41","spread":"0.880"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.018","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-3.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.43","ciUpperLimit":"-0.61"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"Values represented under \"Geometric Least Square Mean\" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.","populationDescription":"All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"Pooled 6 mg/12 mg/36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, 12 mg and 36 mg, which was maintained through Week 72, unless dose modification was required. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"607"},{"groupId":"OG001","value":"949"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.70","spread":"1.688"},{"groupId":"OG001","value":"-17.59","spread":"1.096"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"Geometric LS Mean Difference (Net)","paramValue":"-13.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.20","ciUpperLimit":"-9.68"}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)","description":"The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health \"now,\" whereas the remaining domains assess functioning \"in the past week.\" Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.","populationDescription":"All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"T-score","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required."},{"id":"OG001","title":"Pooled 6 mg/12 mg/36 mg Orforglipron QD","description":"Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, 12 mg and 36 mg, which was maintained through Week 72, unless dose modification was required. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"629"},{"groupId":"OG001","value":"983"}]}],"classes":[{"title":"Physical Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"0.42","spread":"0.271"},{"groupId":"OG001","value":"1.47","spread":"0.219"}]}]},{"title":"Mental Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"0.270"},{"groupId":"OG001","value":"-0.10","spread":"0.215"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Physical Component Score- Values represented under LS Mean are MBE of the unconditional average treatment effect. MBE was calculated using a MMRM for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","nonInferiorityType":"SUPERIORITY","pValue":"0.003","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"1.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.36","ciUpperLimit":"1.73"},{"groupIds":["OG000","OG001"],"groupDescription":"Mental Component Score- Values represented under LS Mean are MBE of the unconditional average treatment effect. MBE was calculated using a MMRM for post-baseline measures with region + Baseline\\*Time\\*Treatment + Strata\\*Time\\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).","nonInferiorityType":"SUPERIORITY","pValue":"0.249","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"0.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"1.07"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Up to Week 74","description":"* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received matching placebo capsule orally once daily. 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