{"protocolSection":{"identificationModule":{"nctId":"NCT04184622","orgStudyIdInfo":{"id":"17244"},"secondaryIdInfos":[{"id":"I8F-MC-GPHK","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight","officialTitle":"Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)","acronym":"SURMOUNT-1"},"statusModule":{"statusVerifiedDate":"2025-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-12-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-04-01","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-06","type":"ACTUAL"},"studyFirstSubmitDate":"2019-12-02","studyFirstSubmitQcDate":"2019-12-02","studyFirstPostDateStruct":{"date":"2019-12-03","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-03-30","resultsFirstSubmitQcDate":"2023-03-30","resultsFirstPostDateStruct":{"date":"2023-04-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-07-03","lastUpdatePostDateStruct":{"date":"2025-07-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years."},"conditionsModule":{"conditions":["Overweight","Obesity"],"keywords":["Metabolism and Nutrition Disorder","Prediabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":2539,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","interventionNames":["Drug: Placebo"]},{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","interventionNames":["Drug: Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight (Primary Treatment Period)","description":"Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)","description":"Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.","timeFrame":"Week 72"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 20"},{"measure":"Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)","description":"Percentage of Participants who Achieve ≥10% Body Weight Reduction","timeFrame":"Week 72"},{"measure":"Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)","description":"Percentage of participants who achieve ≥15% body weight reduction.","timeFrame":"Week 72"},{"measure":"Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)","description":"Percentage of participants who achieve ≥20% body weight reduction.","timeFrame":"Week 72"},{"measure":"Change From Baseline in Waist Circumference (Primary Treatment Period)","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period","description":"The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 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\" while the remaining domains assess functioning \"in the past week.\" Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)","description":"LS Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 176"},{"measure":"Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)","description":"The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.\n\nTime to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.","timeFrame":"Baseline through Week 176"},{"measure":"Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)","description":"The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.\n\nTime to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.","timeFrame":"Baseline through Week 193"},{"measure":"Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Fasting Glucose (Primary Treatment Period)","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","timeFrame":"Baseline, Week 72"},{"measure":"Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","timeFrame":"Baseline, Week 72"},{"measure":"Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)","description":"Percentage of Participants Who Achieve ≥5% Body Weight Reduction.","timeFrame":"Week 176"},{"measure":"Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 (Primary Treatment Period)","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcomes (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.","timeFrame":"Baseline, Week 72"},{"measure":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)","description":"PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.","timeFrame":"Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease\n* History of at least one unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Change in body weight greater than 5 kg within 3 months prior to starting study\n* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity\n* History of pancreatitis\n* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years\n* Any lifetime history of a suicide attempt","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 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Evaluation of clinical relevance of weight nadirs and weight regain during 3 years of treatment with tirzepatide in participants with obesity or overweight and prediabetes. Obes Pillars. 2026 Sep 18;20:100333. doi: 10.1016/j.obpill.2026.100333. eCollection 2026 Dec."},{"pmid":"42348366","type":"DERIVED","citation":"Kokkinos A, Thethi T, Lee CJ, Neff LM, Stefanski A, Cao D, Rodriguez A, Bartee A. Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials. Diabetes Obes Metab. 2026 Sep;28(9):8367-8377. doi: 10.1111/dom.71009. Epub 2026 Jun 25."},{"pmid":"42233927","type":"DERIVED","citation":"Sattar N, Linetzky B, Ruotolo G, Verma S, Sourij H, Wang H, Vanderman K, Wilson JM, Griffin RM, Stefanski A, Ridker PM. Comprehensive Long-Term Changes in Cardiovascular Risk Biomarkers With Tirzepatide: A SURMOUNT-1 Post Hoc Analysis. J Am Coll Cardiol. 2026 Jun 3:S0735-1097(26)06416-8. doi: 10.1016/j.jacc.2026.04.044. Online ahead of print."},{"pmid":"41885866","type":"DERIVED","citation":"Galindo RJ, Gudzune KA, Look M, Lee CJ, Benabbad I, Cao D, Meng Q, Mojdami D. Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. JAMA Netw Open. 2026 Mar 2;9(3):e263274. doi: 10.1001/jamanetworkopen.2026.3274."},{"pmid":"41612966","type":"DERIVED","citation":"Ishigaki Y, Yamada M, Shingaki T, Oura T, Shimomura I. Efficacy and Safety of Tirzepatide in Japanese Participants With Obesity: A Subpopulation Analysis of the SURMOUNT-1 Trial. Obesity (Silver Spring). 2026 Mar;34(3):608-621. doi: 10.1002/oby.70131. Epub 2026 Jan 30."},{"pmid":"41537305","type":"DERIVED","citation":"Wadden TA, Oquendo MA, Kushner RF, Cao D, Karanikas CA, Kechter A, Murphy MA. Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Obesity (Silver Spring). 2026 Mar;34(3):565-578. doi: 10.1002/oby.70122. Epub 2026 Jan 15."},{"pmid":"41187013","type":"DERIVED","citation":"Li X, Cao D, Sapin H, Wang F, Hunter Gibble T, Raibulet NK, Denning M, Kaplan LM. People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Obesity (Silver Spring). 2026 Jan;34(1):114-126. doi: 10.1002/oby.70067. Epub 2025 Nov 4."},{"pmid":"40717199","type":"DERIVED","citation":"Gourgari E, Srivastava G, Kelly AS, Mojdami D, Cao D, Murphy MA, Karanikas CA, Lee CJ. Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Obesity (Silver Spring). 2025 Sep;33(9):1668-1679. doi: 10.1002/oby.24348. Epub 2025 Jul 27."},{"pmid":"40677091","type":"DERIVED","citation":"Ard J, Lee CJ, Gudzune K, Addison B, Lingvay I, Cao D, Mast CJ, Stefanski A, Falcon B, Mojdami D. Weight reduction over time in tirzepatide-treated participants by early weight loss response: Post hoc analysis in SURMOUNT-1. Diabetes Obes Metab. 2025 Sep;27(9):5064-5071. doi: 10.1111/dom.16554. Epub 2025 Jul 17."},{"pmid":"40659850","type":"DERIVED","citation":"Ramirez S, Yang R, Habibovic M, Kennedy S, Bennett JP, Shepherd JA, Thomas DM, Heymsfield SB. Visual demonstration of weight loss and health risk improvement with a dual GIP and GLP-1 receptor agonist. Int J Obes (Lond). 2025 Oct;49(10):2005-2010. doi: 10.1038/s41366-025-01842-1. Epub 2025 Jul 14."},{"pmid":"40550133","type":"DERIVED","citation":"Linetzky B, Sattar N, Verma S, Krumholz HM, Xie CC, Hoffmann HT, Zimner-Rapuch S, Torcello-Gomez A, Stefanski A. Improvements in Cardiometabolic Risk Factors by Weight Reduction: A Post Hoc Analysis of Adults With Obesity Randomly Assigned to Tirzepatide. Ann Intern Med. 2025 Aug;178(8):1095-1105. doi: 10.7326/ANNALS-24-02623. Epub 2025 Jun 24."},{"pmid":"40512543","type":"DERIVED","citation":"Heerspink HJL, Friedman AN, Bjornstad P, van Raalte DH, Cherney D, Cao D, Garcia-Perez LE, Stefanski A, Turfanda I, Bunck MC, Benabbad I, Griffin R, Piras de Oliveira C. Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. J Am Soc Nephrol. 2025 Nov 1;36(11):2190-2200. doi: 10.1681/ASN.0000000764. Epub 2025 Jun 13."},{"pmid":"39800653","type":"DERIVED","citation":"Horn DB, Kahan S, Batterham RL, Cao D, Lee CJ, Murphy M, Gonsahn-Bollie S, Chigutsa F, Stefanski A, Dunn JP. Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials. Clin Obes. 2025 Jun;15(3):e12734. doi: 10.1111/cob.12734. Epub 2025 Jan 12."},{"pmid":"39536238","type":"DERIVED","citation":"Jastreboff AM, le Roux CW, Stefanski A, Aronne LJ, Halpern B, Wharton S, Wilding JPH, Perreault L, Zhang S, Battula R, Bunck MC, Ahmad NN, Jouravskaya I; SURMOUNT-1 Investigators. Tirzepatide for Obesity Treatment and Diabetes Prevention. N Engl J Med. 2025 Mar 6;392(10):958-971. doi: 10.1056/NEJMoa2410819. Epub 2024 Nov 13."},{"pmid":"39497468","type":"DERIVED","citation":"Gudzune KA, Stefanski A, Cao D, Mojdami D, Wang F, Ahmad N, Ling Poon J. Association between weight reduction achieved with tirzepatide and quality of life in adults with obesity: Results from the SURMOUNT-1 study. Diabetes Obes Metab. 2025 Feb;27(2):539-550. doi: 10.1111/dom.16046. Epub 2024 Nov 4."},{"pmid":"39084707","type":"DERIVED","citation":"Krumholz HM, de Lemos JA, Sattar N, Linetzky B, Sharma P, Mast CJ, Ahmad NN, Bunck MC, Stefanski A. Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial. Heart. 2024 Sep 16;110(19):1165-1171. doi: 10.1136/heartjnl-2024-324170."},{"pmid":"38314555","type":"DERIVED","citation":"de Lemos JA, Linetzky B, le Roux CW, Laffin LJ, Vongpatanasin W, Fan L, Hemmingway A, Ahmad NN, Bunck MC, Stefanski A. Tirzepatide Reduces 24-Hour Ambulatory Blood Pressure in Adults With Body Mass Index >/=27 kg/m2: SURMOUNT-1 Ambulatory Blood Pressure Monitoring Substudy. Hypertension. 2024 Apr;81(4):e41-e43. doi: 10.1161/HYPERTENSIONAHA.123.22022. Epub 2024 Feb 5. No abstract available."},{"pmid":"37700443","type":"DERIVED","citation":"Hankosky ER, Wang H, Neff LM, Kan H, Wang F, Ahmad NN, Stefanski A, Garvey WT. Tirzepatide reduces the predicted risk of developing type 2 diabetes in people with obesity or overweight: Post hoc analysis of the SURMOUNT-1 trial. Diabetes Obes Metab. 2023 Dec;25(12):3748-3756. doi: 10.1111/dom.15269. Epub 2023 Sep 12."},{"pmid":"35658024","type":"DERIVED","citation":"Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight","url":"https://trials.lillytrialguide.com/en-US/trial/1o8ZY82Yn01Z4Hqvx0WuME"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. 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No treatment was administered during this period."},{"id":"FG002","title":"10 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). 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with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"635"},{"groupId":"OG001","value":"623"},{"groupId":"OG002","value":"629"},{"groupId":"OG003","value":"625"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.26"},{"groupId":"OG001","value":"31.62"},{"groupId":"OG002","value":"55.48"},{"groupId":"OG003","value":"62.88"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"36.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.37","ciUpperLimit":"74.22"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"109.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"54.50","ciUpperLimit":"219.81"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"150.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"74.85","ciUpperLimit":"302.97"}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference (Primary Treatment Period)","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline weight circumference value, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"centimeters","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG002","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG003","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"634"},{"groupId":"OG001","value":"622"},{"groupId":"OG002","value":"629"},{"groupId":"OG003","value":"625"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.4","spread":"0.42"},{"groupId":"OG001","value":"-14.6","spread":"0.41"},{"groupId":"OG002","value":"-19.4","spread":"0.41"},{"groupId":"OG003","value":"-19.9","spread":"0.41"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-11.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.3","ciUpperLimit":"-10.0"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-16.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.2","ciUpperLimit":"-14.9"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-16.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.7","ciUpperLimit":"-15.4"}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period","description":"The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 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\" while the remaining domains assess functioning \"in the past week.\" Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline SF-36v2 value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg or 15mg, which was then maintained up to Week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"1080"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"0.27"},{"groupId":"OG001","value":"4.0","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.6","ciUpperLimit":"2.9"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least one post-baseline triglyceride value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"612"},{"groupId":"OG001","value":"1822"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.3","spread":"1.55"},{"groupId":"OG001","value":"-27.6","spread":"0.66"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-22.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-25.6","ciUpperLimit":"-19.8"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"612"},{"groupId":"OG001","value":"1822"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.11","spread":"0.695"},{"groupId":"OG001","value":"-5.97","spread":"0.364"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-4.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.40","ciUpperLimit":"-3.41"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol HDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"581"},{"groupId":"OG001","value":"1764"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"0.757"},{"groupId":"OG001","value":"7.92","spread":"0.447"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"7.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.85","ciUpperLimit":"9.49"}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline SBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeter of mercury (mmHg)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"634"},{"groupId":"OG001","value":"1878"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.48"},{"groupId":"OG001","value":"-8.1","spread":"0.27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-6.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.9","ciUpperLimit":"-5.7"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least one post-baseline fasting insulin value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"1779"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"2.60"},{"groupId":"OG001","value":"-46.9","spread":"0.83"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-41.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-44.9","ciUpperLimit":"-37.3"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)","description":"LS Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"Participants with prediabetes at randomization who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 176","groups":[{"id":"OG000","title":"Placebo","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176."},{"id":"OG001","title":"5 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176."},{"id":"OG002","title":"10 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176."},{"id":"OG003","title":"15 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"260"},{"groupId":"OG003","value":"249"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"0.78"},{"groupId":"OG001","value":"-15.4","spread":"0.74"},{"groupId":"OG002","value":"-19.9","spread":"0.72"},{"groupId":"OG003","value":"-22.9","spread":"0.73"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-13.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.3","ciUpperLimit":"-11.1"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-17.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-19.8","ciUpperLimit":"-15.7"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-20.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-22.8","ciUpperLimit":"-18.6"}]},{"type":"SECONDARY","title":"Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)","description":"The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.\n\nTime to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.","populationDescription":"Participants with prediabetes at randomization who received at least one dose of study drug (including the censored participants). Number of participants censored in Placebo = 236, Pooled 5 mg/10 mg/15 mg Tirzepatide = 753.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Baseline through Week 176","groups":[{"id":"OG000","title":"Placebo","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5mg,10 mg or 15mg, tirzepatide dose SC QW until week 176."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"762"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.6"},{"groupId":"OG001","value":"1.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.03","ciUpperLimit":"0.13"}]},{"type":"SECONDARY","title":"Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)","description":"The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.\n\nTime to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.","populationDescription":"Participants with prediabetes at randomization who received at least one dose of study drug (including the censored participants). Number of participants censored in Placebo = 233, Pooled 5 mg/10 mg/15 mg Tirzepatide = 744.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Baseline through Week 193","groups":[{"id":"OG000","title":"Placebo","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193)."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5mg,10 mg or 15mg, tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"762"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.7"},{"groupId":"OG001","value":"2.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.07","ciUpperLimit":"0.21"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms per meter squared (kg/m^2)","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG002","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG003","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"635"},{"groupId":"OG001","value":"623"},{"groupId":"OG002","value":"629"},{"groupId":"OG003","value":"625"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"0.16"},{"groupId":"OG001","value":"-5.9","spread":"0.16"},{"groupId":"OG002","value":"-8.1","spread":"0.16"},{"groupId":"OG003","value":"-8.6","spread":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-5.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.5","ciUpperLimit":"-4.6"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-7.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.7","ciUpperLimit":"-6.8"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-7.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.2","ciUpperLimit":"-7.3"}]},{"type":"SECONDARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline HbA1c value, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG002","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG003","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"612"},{"groupId":"OG001","value":"607"},{"groupId":"OG002","value":"607"},{"groupId":"OG003","value":"608"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.012"},{"groupId":"OG001","value":"-0.40","spread":"0.012"},{"groupId":"OG002","value":"-0.49","spread":"0.012"},{"groupId":"OG003","value":"-0.51","spread":"0.012"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"-0.30"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-0.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"-0.38"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"-0.41"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Glucose (Primary Treatment Period)","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline fasting glucose value, excluding data after prematurely stopping study drug.","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":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG002","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG003","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"612"},{"groupId":"OG001","value":"608"},{"groupId":"OG002","value":"606"},{"groupId":"OG003","value":"608"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"0.514"},{"groupId":"OG001","value":"-7.73","spread":"0.484"},{"groupId":"OG002","value":"-9.73","spread":"0.486"},{"groupId":"OG003","value":"-10.55","spread":"0.486"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-8.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.97","ciUpperLimit":"-7.20"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-10.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.98","ciUpperLimit":"-9.21"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-11.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.80","ciUpperLimit":"-10.30"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had a baseline and at least one post-baseline LDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg,10 mg or 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"578"},{"groupId":"OG001","value":"1754"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.85","spread":"1.076"},{"groupId":"OG001","value":"-6.86","spread":"0.555"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-6.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.32","ciUpperLimit":"-3.75"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline VLDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg,10 mg or 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"577"},{"groupId":"OG001","value":"1754"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.6","spread":"1.55"},{"groupId":"OG001","value":"-27.6","spread":"0.65"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-23.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-26.1","ciUpperLimit":"-20.4"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"Results are reported as model-based estimate and SE from MMRM analysis using log transformation.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline free fatty acids value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"576"},{"groupId":"OG001","value":"1756"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.1","spread":"2.65"},{"groupId":"OG001","value":"-5.9","spread":"1.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Estimate Difference","paramValue":"-11.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.1","ciUpperLimit":"-6.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period","description":"LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\\*time (Type III sum of squares) in the model.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline DBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"Pooled 5 mg/10 mg/15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"634"},{"groupId":"OG001","value":"1878"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"0.35"},{"groupId":"OG001","value":"-5.3","spread":"0.19"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Net)","paramValue":"-4.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.0","ciUpperLimit":"-3.5"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)","description":"Percentage of Participants Who Achieve ≥5% Body Weight Reduction.","populationDescription":"Participants with prediabetes at randomization who received at least one dose of study drug and had baseline and at least one post-baseline value for body weight, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 176","groups":[{"id":"OG000","title":"Placebo","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176."},{"id":"OG001","title":"5 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176."},{"id":"OG002","title":"10 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176."},{"id":"OG003","title":"15 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"260"},{"groupId":"OG003","value":"249"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.62"},{"groupId":"OG001","value":"90.61"},{"groupId":"OG002","value":"91.92"},{"groupId":"OG003","value":"94.78"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"29.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"17.73","ciUpperLimit":"50.05"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"35.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"20.63","ciUpperLimit":"59.53"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"55.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"29.61","ciUpperLimit":"102.34"}]},{"type":"SECONDARY","title":"Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 (Primary Treatment Period)","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcomes (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.","populationDescription":"All participants who received at least one dose of study drug and had baseline and at least one post-baseline IWQOL-Lite CT value, excluding data after prematurely stopping study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"Placebo","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks."},{"id":"OG001","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG002","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG003","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"545"},{"groupId":"OG002","value":"539"},{"groupId":"OG003","value":"535"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.1","spread":"0.78"},{"groupId":"OG001","value":"17.8","spread":"0.73"},{"groupId":"OG002","value":"20.7","spread":"0.73"},{"groupId":"OG003","value":"21.8","spread":"0.73"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"7.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.6","ciUpperLimit":"9.8"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"10.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.6","ciUpperLimit":"12.8"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Net)","paramValue":"11.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"9.6","ciUpperLimit":"13.8"}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)","description":"PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.","populationDescription":"All randomly assigned participants who are exposed to at least one dose of study drug who had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms*hours per milliliter (ng*h/mL)","timeFrame":"Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"626"},{"groupId":"OG001","value":"629"},{"groupId":"OG002","value":"625"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88900","spread":"20.2"},{"groupId":"OG001","value":"177000","spread":"22.0"},{"groupId":"OG002","value":"266000","spread":"20.4"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to Week 193","description":"* All randomized participants who received at least 1 dose of the study drug.\n* As per the pre-specified statistical analysis plan, safety data were analyzed and reported by randomized arms regardless of the actual treatment received by the participant.\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":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","deathsNumAffected":4,"deathsNumAtRisk":643,"seriousNumAffected":53,"seriousNumAtRisk":643,"otherNumAffected":315,"otherNumAtRisk":643},{"id":"EG001","title":"5 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","deathsNumAffected":4,"deathsNumAtRisk":630,"seriousNumAffected":57,"seriousNumAtRisk":630,"otherNumAffected":443,"otherNumAtRisk":630},{"id":"EG002","title":"10 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","deathsNumAffected":3,"deathsNumAtRisk":636,"seriousNumAffected":60,"seriousNumAtRisk":636,"otherNumAffected":451,"otherNumAtRisk":636},{"id":"EG003","title":"15 mg Tirzepatide","description":"* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.\n* Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176.\n* Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.","deathsNumAffected":2,"deathsNumAtRisk":630,"seriousNumAffected":50,"seriousNumAtRisk":630,"otherNumAffected":429,"otherNumAtRisk":630}],"seriousEvents":[{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":643},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":630},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":636},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":630}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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