| Outcome Measures: |
Primary: Percent Change From Randomization in Body Weight at Week 88, Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88 | Secondary: Percent Change From Randomization in Body Weight at Week 64, LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 64|Change From Randomization in Body Weight, LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Waist Circumference, LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Body Mass Index (BMI), LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Fasting Glucose, LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Hemoglobin A1c (HbA1c), LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Percent Change From Randomization in Fasting Insulin, LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA)), LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score, The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (\< 10%, \>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables., Randomization (Week 36), Week 88|Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score, The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life. LS mean was analysed by ANCOVA model with randomization + analysis Country + sex + weight loss at Week 36 (\< 10%, \>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables., Randomization (Week 36), Week 88|Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period, Percentage of Participants Who Maintain at least 80% of the Body Weight Lost During the Open-Label Lead-In Period was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment\*Time as variables., Week 88|Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline, Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction from baseline was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment\*Time as variables., Baseline (Week 0) to Week 88|Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period, Time to first occurrence of participants returning to \>95% baseline weight for those who lost ≥5% during the open-label lead-in period., Randomization (Week 36) to Week 88|Change From Baseline in BMI, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + BMI at randomization (kg/m\^2) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in Body Weight, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Percent Change From Baseline in Body Weight, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in Waist Circumference, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in Fasting Glucose, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in HbA1c, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Percent Change From Baseline in Fasting Insulin, LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs), LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in SBP, DBP, LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score, The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (\< 10%, \>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables., Baseline (Week 0), Week 88|Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score, The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life. LS mean was analysed by ANCOVA model with baseline + analysis Country + sex + weight loss at Week 36 (\< 10%, \>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables., Baseline (Week 0), Week 88
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| Locations: |
Cahaba Research, Pelham, Alabama, 35124, United States|Scripps Memorial Hospital La Jolla, La Jolla, California, 92037, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|National Research Institute, Panorama City, California, 91402, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|New West Physicians Clinical Research, Golden, Colorado, 80401, United States|Optumcare Colorado Springs - Monument, Monument, Colorado, 80132, United States|Care Partners Clinical Research, Jacksonville, Florida, 32277, United States|South Florida Clinical Research Institute, Margate, Florida, 33063, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|ForCare Clinical Research, Tampa, Florida, 33613, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|SKY Clinical Research Network Group-Blake, Union City, Georgia, 30291, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Healthcare Research Network - Chicago, Flossmoor, Illinois, 60422, United States|Clinical Investigation Specialists, Gurnee, Illinois, 60031, United States|Midwest Institute For Clinical Research, Indianapolis, Indiana, 46260, United States|American Health Network of Indiana, LLC - New Albany, New Albany, Indiana, 47150, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Centennial Medical Group, Elkridge, Maryland, 21075, United States|MedStar Health Research Institute (MedStar Physician Based Research Network), Hyattsville, Maryland, 20782, 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|Glacier View Research Institute - Endocrinology, Kalispell, Montana, 59901, United States|Weill Cornell Medical College, New York, New York, 10065, 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|Lillestol Research, Fargo, North Dakota, 58104, United States|Aventiv Research Inc, Columbus, Ohio, 43213, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Summit Research Network, Portland, Oregon, 97210, United States|Capital Area Research, LLC, Camp Hill, Pennsylvania, 17011, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|The University of Texas Health Science Center at Houston, Bellaire, Texas, 77401, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Biopharma Informatic, LLC, Houston, Texas, 77043, United States|North Hills Family Medicine/North Hills Medical Research, North Richland Hills, Texas, 76180, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Northwest Houston Heart Center, Tomball, Texas, 77375, United States|Health Research of Hampton Roads, Inc., Newport News, Virginia, 23606, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|CEDIC, Caba, Buenos Aires, C1060ABN, Argentina|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Stat Research S.A., Ciudad Autónoma de Buenos Aire, Buenos Aires, C1023AAB, Argentina|Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aire, C1128AAF, Argentina|Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, C1425AGC, Argentina|Instituto Médico Catamarca IMEC, Rosario, Santa Fe, 2000, Argentina|Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, C1419AHN, Argentina|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Cline Research Center, Curitiba, Paraná, 80030-480, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul, Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|Centro de Pesquisa Sao Lucas, Campinas, São Paulo, 13034-685, Brazil|BR Trials - Ensaios Clinicos e Consultoria, Sao Paulo, São Paulo, 03325-050, Brazil|ISPEM - Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos, São Paulo, 12243-280, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, 22241-180, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|Centro de Endocrinologia Alcantara Gonzalez, Bayamon, 00959, Puerto Rico|Private Practice Dr. Martha Gomez Cuellar, San Juan, 00921, Puerto Rico|Wellness clinical Research Vega Baja, Vega Baja, 00694, Puerto Rico|Chung Shan Medical University Hospital, Taichung, 402, Taiwan|China Medical University Hospital, Taichung, 40447, Taiwan|National Cheng-Kung Uni. Hosp., Tainan, 704, Taiwan|National Taiwan University Hospital, Taipei, 10002, Taiwan
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