| Outcome Measures: |
Primary: Percent Change From Baseline in Body Weight, Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline, Percentage of participants who achieve ≥5% body weight reduction from baseline, Week 72 | Secondary: Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline, Percentage of participants who achieve ≥10% body weight reduction from baseline, Week 72|Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline, Percentage of participants who achieve ≥15% body weight reduction from baseline, Week 72|Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline, Percentage of participants who achieve ≥20% body weight reduction from baseline, Week 72|Change From Baseline in Absolute Body Weight, LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Change From Baseline in Body Mass Index (BMI), LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Change From Baseline in Hemoglobin A1c (HbA1c), LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Percentage of Participants Who Achieve HbA1c <7%, Percentage of participants who achieve HbA1c \<7%, Week 72|Percentage of Participants Who Achieve HbA1c ≤6.5%, Percentage of participants who achieve HbA1c ≤6.5%, Week 72|Percentage of Participants Who Achieve HbA1c <5.7%, Percentage of participants who achieve HbA1c \<5.7%, Week 72|Change From Baseline in Fasting Glucose, LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Change From Baseline in Waist Circumference, LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg), Results are reported as model-based estimates 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 10 mg and 15 mg), Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg), Results are reported as model-based estimates 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 10 mg and 15 mg), Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg), Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg), Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide), Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide), LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide), LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 72|Percent Change From Baseline in Fasting Insulin, Results are reported as model-based estimates and SE from MMRM analysis using log transformation., Baseline, Week 72|Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score, 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, The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (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|Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide, Each participant was 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. The steady state AUC was evaluated using Population PK modeling., Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
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| Locations: |
University of Alabama - Department of Nutrition Sciences, Birmingham, Alabama, 35294, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, 72205, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, 90255, United States|Velocity Clinical Research, Westlake, 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|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Northeast Research Institute (NERI), Fleming Island, Florida, 32003, United States|New Horizon Research Center, Miami, Florida, 33165, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Emory University School of Medicine- Grady Campus, Atlanta, Georgia, 30303, United States|East Coast Institute for Research, LLC, Macon, Georgia, 31210, United States|Pacific Diabetes & Endocrine Center, Honolulu, Hawaii, 96813, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|American Health Network of Indiana, LLC - Greenfield, Greenfield, Indiana, 46140, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Cotton O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|Maryland Cardiovascular Specialists, Baltimore, Maryland, 21229, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States|Logan Health Research, Kalispell, Montana, 59901, United States|Premier Research, Trenton, New Jersey, 08611, United States|University of North Carolina Medical Center, Chapel Hill, North Carolina, 27514, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Wake Forest University Baptist Medical Center (WFUBMC), Winston-Salem, North Carolina, 27157, United States|Velocity Clinical Research, Cleveland, Cleveland, Ohio, 44122, United States|Aventiv Research, Dublin, Ohio, 43016, United States|The Corvallis Clinic, P.C., Corvallis, Oregon, 97330, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Center for Neurosciences, Warwick, Rhode Island, 02886, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78749, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|Juno Research, Houston, Texas, 77040, United States|Endocrine Ips, Pllc, Houston, Texas, 77079, United States|Health Research of Hampton Roads, Inc., Newport News, Virginia, 23606, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Clinical Investigation Specialists, Kenosha, Wisconsin, 53144, United States|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BUB, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina|Go Centro Medico San Nicolás, San Nicolas, Buenos Aires, 2900, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aire, C1120AAC, Argentina|CIPREC, Caba, Ciudad Autónoma De Buenos Aire, C1061AAS, Argentina|Centro de Investigaciones Médicas Tucuman, SAN M. DE Tucuman, Tucumán, T4000AXL, Argentina|Sanatorio Norte, Santiago del Estero, 4200, Argentina|Private Practice - Dr.Miguel N. Hissa, Fortaleza, Ceará, 60430-350, Brazil|Loema Instituto de Pesquisa Clinica, Campinas, São Paulo, 13010-001, Brazil|Instituto de Pesquisa clinica de Campinas, Campinas, São Paulo, 13060-080, Brazil|CECIP - Centro de Estudos do Interior Paulista, Jaú, São Paulo, 17201130, Brazil|CPCLIN, Sao Paulo, São Paulo, 01228-200, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Life Care Hospital and Research Centre, Bangalore, Karnataka, 560092, India|ILS Hospitals, Kolkata, West Bengal, 700064, India|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|Medical Corporation Sato Medical clinic, Ootaku, Tokyo, 143-0015, Japan|AMC Nishiumeda Clinic, Osaka, 530-0001, Japan|Centro de Endocrinologia y Nutricion, Caguas, 00725, Puerto Rico|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, 917, Puerto Rico|Endocrinology Research Center of Rosmedtechnologies, Moscow, Moskva, 117036, Russian Federation|Russian Medical Academy of Postgraduate Education, Moscow, Moskva, 125284, Russian Federation|Saint-Petersburg City Hospital of Saint Elizabeth, Saint Petersburg, Sankt-Pete, 195257, Russian Federation|Smolensk State Medical University, Smolensk, 214019, Russian Federation|Changhua Christian Hospital, Changhua County, Changhua, 50006, Taiwan|Chi Mei Medical Center, Tainan City, Tainan, 71004, Taiwan|Chung Shan Medical University Hospital, Taichung, 402, Taiwan|Taichung Veterans General Hospital, Taichung, 407, Taiwan|National Cheng-Kung Uni. Hosp., Tainan, 704, Taiwan
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