| Outcome Measures: |
Primary: Percent Change From Baseline in Body Weight, Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction, Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors., Week 72 | Secondary: Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program, Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors., 72 Weeks|Percentage of Participants Who Achieve ≥10%Body Weight Reduction, Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors., 72 Weeks|Percentage of Participants Who Achieve ≥15% Body Weight Reduction, Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors., 72 Weeks|Percentage of Participants Who Achieve ≥20% Body Weight Reduction, Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors., 72 Weeks|Change From Baseline in Waist Circumference, Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Body Weight, Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Body Mass Index (BMI), Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Systolic Blood Pressure (SBP), Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Diastolic Blood Pressure (DBP), Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Total Cholesterol, Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol, Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol, Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol, Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Triglycerides, Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Free Fatty Acids, Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Fasting Glucose, Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|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 determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Percent Change From Baseline in Fasting Insulin, Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, 72 Weeks|Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (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 determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables., Baseline, 72 Weeks|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 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 determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables., Baseline, 72 Weeks
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| Locations: |
National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|National Research Institute (NRI) - Santa Ana, Santa Ana, California, 92704, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Precision Clinical Research, Sunrise, Florida, 33351, United States|Clinical Research of West Florida, Tampa, Florida, 33606, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Elite Clinical Trials, Rexburg, Idaho, 83440, United States|Evanston Premier Healthcare Research LLC, Evanston, Illinois, 60201, United States|American Health Network of IN, LLC, Avon, Indiana, 46123, United States|American Health Network of IN, LLC, Franklin, Indiana, 46131, United States|American Health Network of IN, LLC, Muncie, Indiana, 47304, United States|Cotton O'Neil Mulvane, Topeka, Kansas, 66606, United States|Tandem Clinical Research,LLC, Marrero, Louisiana, 70072, United States|The National Diabetes & Obesity Research Institute, Biloxi, Mississippi, 39532, United States|Clinvest Research LLC, Springfield, Missouri, 65810, United States|Quality Clinical Research, Omaha, Nebraska, 68114, United States|Palm Research Center Sunset, Las Vegas, Nevada, 89148, United States|Rochester Clinical Research, Inc., 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|Wake Forest University Baptist Medical Center (WFUBMC), Winston-Salem, North Carolina, 27157, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44122, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Summit Research Network, Portland, Oregon, 97210, United States|Detweiler Family Medicine & Associates, Lansdale, Pennsylvania, 19446, United States|Penn Medicine: University of Pennsylvania Health System, Philadelphia, Pennsylvania, 19104, United States|Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh, Pennsylvania, 15243, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Vanderbilt Health One Hundred Oaks, Nashville, Tennessee, 37204, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Juno Research, Houston, Texas, 77040, 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|Health Research of Hampton Roads, Inc., Newport News, Virginia, 23606, United States|MultiCare Institute for Research & Innovation, Tacoma, Washington, 98405, United States|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Investigaciones Medicas Imoba Srl, Caba, Buenos Aires, C1179AAB, Argentina|Instituto Centenario, Caba, Buenos Aires, C1204AAD, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina|Stat Research S.A., Ciudad Autónoma de Buenos Aire, Buenos Aires, C1023AAB, Argentina|Glenny Corp, Buenos Aires, Ciudad Autónoma De Buenos Aire, 1430, Argentina|CEMEDIAB, C.a.b.a., Ciudad Autónoma De Buenos Aire, C1205AAO, Argentina|Instituto Médico Especializado (IME), Buenos Aires, 1405, Argentina|Sanatorio Norte, Santiago del Estero, 4200, Argentina|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Cline Research Center, Curitiba, Paraná, 80030-480, Brazil|Quanta Diagnóstico e Terapia, Curitiba, Paraná, 80040-110, Brazil|CPCLIN, Sao Paulo, São Paulo, 01228-200, Brazil|BR Trials - Ensaios Clinicos e Consultoria, Sao Paulo, São Paulo, 03325-050, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, 22241-180, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Advanced Clinical Research, LLC, Bayamon, 00961, Puerto Rico|Manati Center for Clinical Research, Manati, 00674, Puerto Rico|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico
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