| Outcome Measures: |
Primary: Percent Change From Baseline in Body Weight, 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., Baseline, Week 72|Percentage of Participants Who Achieve ≥5% Body Weight Reduction, Percentage of participants who achieve ≥5% body weight reduction., Week 72 | Secondary: Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg), 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., Baseline, Week 20|Percent Change From Baseline in Body Weight, Percent Change from Baseline in Body Weight., Baseline, Week 176|Percentage of Participants Who Achieve ≥10% Body Weight Reduction, Percentage of Participants who Achieve ≥10% Body Weight Reduction, Week 72|Percentage of Participants Who Achieve ≥15% Body Weight Reduction, Percentage of participants who achieve ≥15% body weight reduction., Week 72|Percentage of Participants Who Achieve ≥5% Body Weight Reduction, Percentage of Participants who Achieve ≥5% Body Weight Reduction., Week 176|Percentage of Participants Who Achieve ≥20% Body Weight Reduction, Percentage of participants who achieve ≥20% body weight reduction., Week 72|Change From Baseline in Waist Circumference, 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., Baseline, Week 72|Change From Baseline in Body Mass Index (BMI), 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., Baseline, Week 72|Change From Baseline in Fasting Glucose, 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., Baseline, Week 72|Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), 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., Baseline, Week 72|Time to Onset of Type 2 Diabetes, Time to Onset of Type 2 Diabetes, Baseline through Week 176|Change From Baseline in Hemoglobin A1c (HbA1c), 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., Baseline, Week 72|Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Results are reported as model-based estimate and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Results are reported as model-based estimate and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Results are reported as model-based estimate and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Results are reported as model-based estimate and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), Results are reported as model-based estimate and SE from MMRM analysis using log transformation., Baseline, Week 72|Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), 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., Baseline, Week 72|Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg), 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., Baseline, Week 72|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), 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., Baseline, Week 72|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, The IWQOL-Lite-CT is a 20-item, obesity-specific 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., Baseline, Week 72|Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide, 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., Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
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| Locations: |
Cahaba Research, Pelham, Alabama, 35124, United States|Perseverance Research Center, Scottsdale, Arizona, 85224, United States|John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Yale University School of Medicine, New Haven, Connecticut, 06519, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Suncoast Research Group, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Renstar Medical Research, Ocala, Florida, 34471, United States|Oviedo Medical Research, Oviedo, Florida, 32765, United States|ForCare Clinical Research, Tampa, Florida, 33613, United States|Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States|Herman Clinical Research, Suwanee, Georgia, 30024, United States|SKY Integrative Medical Center/SKYCRNG, Union City, Georgia, 30291, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, 46260, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, 66606, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|ActivMed Practices and Research, Methuen, Massachusetts, 01844, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States|StudyMetrix Research, Saint Peters, Missouri, 63303, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Palm Research Center Sunset, Las Vegas, Nevada, 89148, United States|Premier Research, Trenton, New Jersey, 08611, United States|NYU Langone Health, New York, New York, 10016, United States|Weill Cornell Medical College, New York, New York, 10021, United States|Rochester Clinical Research, LLC, Rochester, New York, 14609, United States|University of North Carolina Medical Center, Chapel Hill, North Carolina, 27514, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Lillestol Research, Fargo, North Dakota, 58104, United States|Velocity Clinical Research, Cleveland, Cleveland, Ohio, 44122, United States|Aventiv Research Inc, Columbus, Ohio, 43213, United States|Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States|Summit Research Network, Portland, Oregon, 97210, United States|Detweiler Family Medicine & Associates, Lansdale, Pennsylvania, 19446, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Velocity Clinical Research, Providence, East Greenwich, Rhode Island, 02818, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Mountain View Clinical Research, Inc., Greer, South Carolina, 29651, United States|Coastal Carolina Research Center, North Charleston, South Carolina, 29405, United States|WR-Clinsearch, LLC, Chattanooga, Tennessee, 37421, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78749, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Stat Research S.A., Caba, Buenos Aires, 1023, Argentina|CEDIC, Caba, Buenos Aires, C1060ABN, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina|DIM Clinica Privada, Ramos Mejía, Buenos Aires, 1704, Argentina|GO Centro Médico San Nicolás, San Nicolás, Buenos Aires, 2900, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1120AAC, Argentina|Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1128AAF, Argentina|CEDOES, Vitoria, Espírito Santo, 29055-450, Brazil|Instituto de Pesquisa clinica de Campinas, Campinas, São Paulo, 13060-080, Brazil|Loema - Instituto de Pesquisa Clinica, Campinas, São Paulo, 13092-133, Brazil|Instituto Brasil de Pesquisa Clínica - IBPCLIN, Rio de Janeiro, 22241-180, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|CPCLIN, São Paulo, 01228-200, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Hospital da Clinicas da Faculdade de Medicina da USP, São Paulo, 05403-000, Brazil|Beijing Tsinghua Changgung Hospital, Changping, Beijing, 102202, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|The First Affiliated Hospital of Xi'an Medical University, Xi'an, Shanxi, 710077, China|West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China|Ningbo First Hospital, Ningbo, Zhejiang, 315010, China|Gujarat Endocrine Center, Ahmedabad, Gujarat, 380006, India|Sir J.J. Group of Hospitals, Mumbai, Maharashtra, 400008, India|Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, 411004, India|Care Hospitals Hyderabad- Banjara Hills, Hyderabad, Telangana, 500034, India|ILS Hospital, Kolkata, West Bengal, 700064, India|Fortis Hospital, Delhi, 110088, India|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|AMC Nishiumeda Clinic, Osaka, 530-0001, Japan|Centro de Investigacion en Artritis y Osteoporosis SC, Mexicali, Baja California, 21200, Mexico|Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Distrito Federal, 11650, Mexico|RM Pharma Specialists, Mexico City, Distrito Federal, 3100, Mexico|Unidad de Investigacion Clinica y Atencion Medica HEPA, Guadalajara, Jalisco, 44670, Mexico|Virgen Cardiovascular Research S.C, Guadalajara, Jalisco, 44670, Mexico|Instituto de Diabetes, Obesidad y Nutricion, Cuernavaca, Morelos, 62250, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico|Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C., Culiacan Rosales, Sinaloa, 80230, Mexico|Investigacion en Salud y Metabolismo S.C, Chihuahua, 31217, Mexico|Arké SMO S.A de C.V, Veracruz, 91910, Mexico|Manati Center for Clinical Research, Manati, 00674, Puerto Rico|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|GCM Medical Group, PSC- Hato Rey Site, San Juan, 00917, Puerto Rico|Private Practice - Dr. Luis Rivera Colon, San Juan, 00921, Puerto Rico|Ivanovo Regional Healthcare Institution Cardiology Dispensary, Ivanovo, Ivanovskaya Oblast', 153012, Russian Federation|Immanuel Kant Baltic Federal University, Kaliningrad, Kaliningradskaya Oblast', 236041, Russian Federation|Endocrinology Research Center of Rosmedtechnologies, Moscow, Moskva, 117036, Russian Federation|Pirogov Russian National Research Medical University, Moscow, Moskva, 117997, Russian Federation|Russian Cardiology Research and Production Complex, Moscow, Moskva, 121552, Russian Federation|State Research Center for Preventive Medicine, Moscow, Moskva, 127051, Russian Federation|Research Institute of Therapy and Preventive Medicine, Novosibirsk, Novosibirskaya Oblast', 630089, Russian Federation|St Petersburg SBHI City Hospital No. 38 Named After Semashko, St. Petersburg, Sankt-Peterburg, 196601, Russian Federation|Izhevsk City Clinical Hospital Number 9, Izhevsk, Udmurtskaya Respublika, 426063, Russian Federation|Chi-Mei Medical Center, Tainan City, Tainan, 71004, Taiwan|National Taiwan University Hospital, Taipei City, Taipei, 10002, Taiwan|Chung Shan Medical University Hospital, Taichung, 402, Taiwan|China Medical University Hospital, Taichung, 40447, Taiwan|National Cheng Kung University Hospital, Tainan, 704, Taiwan
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