| Outcome Measures: |
Primary: Percent Change From Baseline in Whole Liver Fat at Week 16, Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)., Baseline, Week 16.|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16, A sufficient amount of blood was collected for the analysis of plasma HbA1c., Baseline, Week 16. | Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. An AE was considered TEAE if the event occurred during the on-treatment period. The causality of AEs were assessed by the investigator using clinical judgement. A severe AE was an event that prevents normal everyday activities., Up to 21 weeks.|Number of Participants With Hypoglycemia TEAEs, Hypoglycemic AEs were routinely monitored during participation in the study. Hypoglycemic AE was defined as 1 of the following: 1. Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemic AE but a plasma glucose value of \<70 milligram per deciliter (mg/dL) using glucometer; 2. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemic AEs were accompanied with a glucose value of \<70 mg/dL using glucometer and the clinical picture included prompt resolution with food intake, subcutaneous glucagon or intravenous (IV) glucose; 3. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemic AEs were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration of \<70 mg/dL, and the clinical picture included prompt resolution with food intake, subcutaneous glucagon, or IV glucose., Up to 21 weeks.|Cumulative Number of Participants With Clinical Laboratory Abnormalities, Clinical laboratory tests included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy). The abnormality criteria were standard sponsor reporting criteria., Up to 21 weeks.|Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria, Vital signs data meeting the following criteria were reported: sitting diastolic blood pressure (DBP) \<50 mmHg or \>= 20 mmHg increase or \>= 20 mmHg decrease, sitting systolic blood pressure (SBP) blood pressure \<90 mmHg or \>=30 mmHg increase or \>=30 mmHg decrease., Up to 21 weeks.|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria, ECG data meeting the following criteria were reported: PR interval value \>=300 msec, QRS interval percent change \>= 50%, QTcF interval value \>450 msec and \<=480 msec, or change \>30 msec and \<=60 msec, or change \>60 msec., Up to 21 weeks.|Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks, Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP., From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.|Change From Baseline in Fasting Insulin Over 16 Weeks, A sufficient amount of blood was collected for the analysis of plasma insulin. The unit of insulin is milli-international units per liter (mIU/L)., From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.|Change From Baseline in Fasting Glucose Over 16 Weeks, A sufficient amount of blood was collected for the analysis of plasma glucose., From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.|Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks, HOMA-IR values were derived from fasting plasma insulin and glucose values. Greater reduction from baseline in HOMA-IR scale values shows greater effects on glycemic metabolism., From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.|Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks, ALT was assessed as one of the clinical laboratory chemistry tests., From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.|Change From Baseline in HbA1c at All Timepoints Other Than Week 16, A sufficient amount of blood was collected for the analysis of plasma HbA1c., From Baseline to Week 2, Week, 4, Week 8, and Week 12.
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| Locations: |
Horizon Clinical Research Associates, PLLC, Gilbert, Arizona, 85295, United States|Clinical Research Consortium an AMR company, Tempe, Arizona, 85207, United States|Anaheim Clinical Trials LLC-Clinical Research, Anaheim, California, 92801, United States|Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Hope Clinical Research, Canoga Park, California, 91303, United States|San Diego Imaging SDI, Chula Vista, California, 91911, United States|Sharp Coronado Hospital, Coronado, California, 92118, United States|Southern California Research Center, Coronado, California, 92118, United States|Holy Trinity Medical Clinic, Harbor City, California, 90710, United States|Innovative Clinical Research, Inc., Harbor City, California, 90710, United States|ICM Medical Group, Inglewood, California, 90301, United States|eStudySite, La Mesa, California, 91942, United States|Clinical Trials Research, Lincoln, California, 95648, United States|National Research Institute, Los Angeles, California, 90057, United States|Renaissance Imaging Medical Associates, Northridge, California, 91328, United States|Huntington Medical Research Institute, Pasadena, California, 91105, United States|Inland Empire Clinical Trials, LLC, Rialto, California, 92377, United States|Diagnostic Radiological Imaging Sacramento, Sacramento, California, 95825, United States|Precision Research Institute, San Diego, California, 92114, United States|Sharp and Children's MRI Center, LLC, San Diego, California, 92123-2731, United States|Sharp & Children's MRI Center, LLC, San Diego, California, 92123, United States|West Coast Radiology, Santa Ana, California, 92705, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Liberty Pacific Advanced Imaging, Tarzana, California, 91356, United States|Advanced Gastroenterology, Thousand Oaks, California, 91360, United States|University Clinical Investigators, Incorporated, Tustin, California, 92780, United States|Independant Imaging, Atlantis, Florida, 33461, United States|Twin Lakes Imaging, Daytona Beach, Florida, 32117, United States|Life Radiology, Doral, Florida, 33122, United States|MD Clinical LLC, Hallandale Beach, Florida, 33009, United States|Borland Groover, Jacksonville, Florida, 32256, United States|Multi-Specialty Research Associates, Inc., Lake City, Florida, 32055, United States|Panax Clinical Research, Miami Lakes, Florida, 33014, United States|Health Care Family Rehab and Research Center, Miami, Florida, 33015, United States|Clinical Research of Miami, Miami, Florida, 33126, United States|Finlay Medical Research, Miami, Florida, 33126, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|Unique Imaging, Miami, Florida, 33137, United States|Y & L Advance Health Care, Inc D/B/A Elite Clinical Research, Miami, Florida, 33144, United States|Stand Up MRI of Miami, Miami, Florida, 33145, United States|Vital Imaging Center, Miami, Florida, 33173, United States|Vital Imaging, Miami, Florida, 33173, United States|Unique Imaging, Miami, Florida, 33180, United States|International Research Associates, Miami, Florida, 33183, United States|Advanced Gastroenterology Associates, LLC, Palm Harbor, Florida, 34684, United States|Rose Radiology, Palm Harbor, Florida, 34685, United States|Castillo & Torres MD PA, Palm Springs, Florida, 33406, United States|Ctmd Research Inc, Palm Springs, Florida, 33406, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Qps-Mra, Llc, South Miami, Florida, 33143, United States|Physicians Research Associates , LLC, Lawrenceville, Georgia, 30046, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Alliance Multispecialty Research, LLC, Wichita, Kansas, 67207, United States|AA MRC, Flint, Michigan, 48504, United States|Nebraska Medicine, Omaha, Nebraska, 68198, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Excel Clinical Research, Las Vegas, Nevada, 89109, United States|Alliance for Multispecialty, LLC, Las Vegas, Nevada, 89119, United States|Desert Radiology, Las Vegas, Nevada, 89128, United States|Pueblo Imaging, Las Vegas, Nevada, 89128, United States|Northwell Imaging of Garden City, Garden City, New York, 11530, United States|Northwell Health - Center for Liver Diseases and Transplantation, Manhasset, New York, 11030, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|Gastroenterology Associates of the Piedmont, PA, Winston-Salem, North Carolina, 27103, United States|PMG Research of Winston Salem, Winston-Salem, North Carolina, 27103, United States|CTI Clinical Research Center, Cincinnati, Ohio, 45212, United States|ProScan, Cincinnati, Ohio, 45227, United States|RAS Health, Marion, Ohio, 43302, United States|Dallas Diabetes and Endocrine Research Center, Dallas, Texas, 75230, United States|Southwest Diagnostics Imaging Center, Dallas, Texas, 75231, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Endocrine IPS, PLLC, Houston, Texas, 77079, United States|The Endocrine Center, Houston, Texas, 77079, United States|Texas Center for Drug Development, Houston, Texas, 77081, United States|Houston Medical Imaging, Houston, Texas, 77098, United States|South Texas Radiology Imaging Centers, Live Oak, Texas, 78233, United States|Clinical Trials of Texas, San Antonio, Texas, 78229, United States|STRIC Northeast Imaging Center, San Antonio, Texas, 78233, United States|Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC), Schertz, Texas, 78154, United States|Clinical Research Partners, LLC, Richmond, Virginia, 23236, United States|Virginia Endoscopy Group, Richmond, Virginia, 23236, United States|VCU Gateway Building Basement, Richmond, Virginia, 23298, United States|Salem VA Medical Center, Salem, Virginia, 24153, United States|Harborview Medical Center Investigational Drug Services, Seattle, Washington, 98104, United States|Harborview Medical Center, Seattle, Washington, 98104, United States|University of Washington Medical Center, Seattle, Washington, 98195, United States|Discovery Clinical Services Ltd., Victoria, British Columbia, V8T 5G4, Canada|West Coast Medical Imaging, Victoria, British Columbia, V8Z0B9, Canada|Nova Scotia Health Authority QE II Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada|Nova Scotia Health Authority QE II Health Sciences Centre, Halifax, Nova Scotia, B3H 2Y9, Canada|Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, B3K 4N1, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|The Western Centre for Functional and Metabolic Mapping, London, Ontario, N6A 5B7, Canada|Oxford Medical Imaging, Mississauga, Ontario, L5R 3K7, Canada|Bluewater Clinical Research Group, Inc., Sarnia, Ontario, N7T 4X3, Canada|St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada|Toronto Liver Centre, Toronto, Ontario, M6H 3M1, Canada|Resonance Magnetique du Saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, G7H 4J1, Canada|Ecogene-21, Chicoutimi, Quebec, G7H 7K9, Canada|Clinique de Medecine Urbaine du Quartier Latin, Montreal, Quebec, H2L 4E9, Canada|McGill University Health Centre (MUHC), Montreal, Quebec, H4A 3J1, Canada|MRI TTT Philips Radiation Oncology, Montreal, Quebec, H4A 3J1, Canada|Radiologie Varad, Montreal, Quebec, H5B1B2, Canada|IRM Quebec, Quebec, G1J 0H4, Canada|Centre de Recherche Saint-Louis, Quebec, G1W4R4, Canada|ALPHA Recherche Clinique Lebourgneuf, Quebec, G2J 0C4, Canada
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