| Outcome Measures: |
Primary: Percent Change in Body Weight from Baseline to Week 48, Baseline and Week 48|Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48, Baseline and Week 48 | Secondary: Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48, Baseline and Week 48|Percentage of Participants with HbA1c <7.0% at Week 48, Week 48|Percent Change in Body Weight from Baseline to Week 28, Baseline and Week 28|Absolute Change in Body Weight (kg) from Baseline to Weeks 28 and 48, Baseline, Weeks 28 and 48|Percent Change in Body Weight from Baseline to Weeks 28 and 48 by Obesity Class, Baseline, Weeks 28 and 48|Change in HbA1c from Baseline to Weeks 16, 28, and 40, Baseline, Weeks 16, 28, and 40|Change in HbA1c from Baseline to Weeks 16, 28, 40, and 48 by Obesity Class, Baseline, Weeks 16, 28, 40, and 48|Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 40, and 48, Weeks 16, 28, 40, and 48|Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 40, and 48, Weeks 16, 28, 40, and 48|Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, and 48, Weeks 16, 28, and 48|Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 28 and 48, Baseline, Weeks 28 and 48|Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 28 and 48, Baseline, Weeks 28 and 48|Change in Body Mass Index (BMI) from Baseline to Week 48, Baseline and Week 48|Change in Waist Circumference from Baseline to Week 48, Baseline and Week 48|Change in Hip Circumference from Baseline to Week 48, Baseline and Week 48|Change in Waist-to-Hip Ratio from Baseline to Week 48, Baseline and Week 48|Change in Waist-to-Height Ratio from Baseline to Week 48, Baseline and Week 48|Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 40, and 48, Baseline, Weeks 16, 28, 40, and 48|Change in Fasting Insulin from Baseline to Weeks 16, 28, 40, and 48, Baseline, Weeks 16, 28, 40, and 48|Change in Fasting C-peptide from Baseline to Weeks 16, 28, 40, and 48, Baseline, Weeks 16, 28, 40, and 48|Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 40, and 48, Baseline, Weeks 16, 28, 40, and 48|Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Weeks 16, 28, 40, and 48, Baseline, Weeks 16, 28, 40, and 48
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| Locations: |
Pinnacle Research Group, Llc; Central, Anniston, Alabama, 36207, United States|University of Alabama at Birmingham (UAB), Birmingham, Alabama, 35233, United States|Lakeview Clinical Research, LLC, Guntersville, Alabama, 35976, United States|AMCR Institute, Escondido, California, 92025, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Asclepes Research Centers, Sherman Oaks, California, 91403, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Excel Medical Clinical Trials, LLC, Boca Raton, Florida, 33434, United States|ASCLEPES Research Centers, Lutz, Florida, 33549, United States|K2 Medical Research, LLC - Maitland, Maitland, Florida, 32751, United States|K2 Medical Research, LLC - Orlando, Maitland, Florida, 32751, United States|K2 Medical Research, LLC - South Orlando, Orlando, Florida, 32806, United States|K2 Medical Research Tampa, Tampa, Florida, 33607, United States|K2 Summit Research, The Villages, Florida, 32159, United States|Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, 30291, United States|Accellacare of Duly Health and Care, Lombard, Illinois, 60148, United States|McFarland Clinic, Ames, Iowa, 50010, United States|NOLA Cares, LLC, Metairie, Louisiana, 70006, United States|Centennial Medical Group, Elkridge, Maryland, 21075, United States|NECCR PrimaCare Research LLC, Fall River, Massachusetts, 02721, United States|Ahmed Arif Medical Research Center (AA MRC LLC), Flint, Michigan, 48504, United States|Olive Branch Family Medical Center; Family Medicine, Olive Branch, Mississippi, 38654, United States|SKY Integrative Medical Center/SKYCRNG, Ridgeland, Mississippi, 39157, United States|Accellacare of Cary, Cary, North Carolina, 27518, United States|Accellacare - Hickory, Hickory, North Carolina, 28601, United States|Accellacare of Rocky Mount, Rocky Mount, North Carolina, 27804, United States|Accellacare of Piedmont Healthcare, Statesville, North Carolina, 28625, United States|Accellacare of Wilmington, LLC, Wilmington, North Carolina, 28401, United States|Accellacare Research of Winston Salem, Winston Salem, North Carolina, 27103, United States|Diabetes and Endocrinology Associates of Stark County, Inc., Canton, Ohio, 44718, United States|Alliance for Multispecialty Research, LLC (AMR Norman), Norman, Oklahoma, 73069, United States|Roper St. Francis Physician Partners - Primary Care, Mount Pleasant, South Carolina, 29464, United States|Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol, Bristol, Tennessee, 37620, United States|Accellacare - Knoxville, Jefferson, Tennessee, 37760, United States|Norwood Family Medicine, Knoxville, Tennessee, 37912, United States|Summit-Halls Family Practice, Knoxville, Tennessee, 37938, United States|Clinical Research Associates, Nashville, Tennessee, 37203, United States|Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States|University of Texas Southwestern Medical Center Investigation Drug Services, Dallas, Texas, 75390, United States|Juno Research, LLC, Houston, Texas, 77040, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States
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