| Outcome Measures: |
Primary: Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS), Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms., 24 weeks of treatment | Secondary: Percentage of Patients With a Decrease From Baseline in IHTG (Quantified by ¹H-MRS) to Week 24 of ≥ 30%., Percentage of patients with a decrease from baseline in IHTG (quantified by ¹H-MRS) to week 24 of ≥ 30% in each group., 24 weeks of treatment.|Percentage of Patients With NAFLD Resolution, Defined as Having ≤ 5.5% IHTG (Quantified by 1H- MRS)., Percentage of patients with NAFLD resolution, defined as having ≤ 5.5% IHTG (quantified by 1H- MRS) in both arms., 24 weeks of treatment.|Improvement in Hepatic Insulin Sensitivity (Hepatic Insulin Resistance Index Reported as Relative Percent Change), Changes from baseline in hepatic insulin sensitivity (Hepatic Insulin Resistance Index) as a relative percent change is presented (i.e. \[24 week result- baseline result\]/baseline result \*100)., 24 weeks of treatment.|Improvement in Adipose Tissue Insulin Sensitivity., Changes from baseline in absolute value of adipose tissue insulin resistance (ADIPO-IR) index will be compared between both arms. This is calculated using the formula below: Adipo-IR index = fasting serum free fatty acid concentration x fasting plasma insulin level. A higher value indicated higher insulin resistance., 24 weeks of treatment.|Improvement in Muscle Insulin Sensitivity (Rd)., Relative percent changes from baseline in insulin-stimulated muscle glucose disposal (%) will be compared between both arms (i.e. \[24 week result- baseline result\]/baseline result \*100)., 24 weeks of treatment.|Absolute Change in Glycemic Control (Hemoglobin A1c)., Absolute changes from baseline will be compared between both arms (i.e., percentage at 24 weeks subtracted from the percentage at baseline)., 24 weeks of treatment.|Change in Plasma HDL-C (mg/dl)., Changes from baseline will be compared between both arms., 24 weeks of treatment.|Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Vibration Controlled Transient Elastography in kPa) on Imaging., Changes from baseline in liver stiffness measurement in kPa by vibration controlled transient elastography measured in both arms., 24 weeks of treatment.|Change in Plasma Biomarkers of Liver Fibrosis (Plasma Cytokeratin 18 Measured in IU/L)., Absolute change (Mean ± SD) changes from baseline in plasma cytokeratin 18 (IU/L) levels in both arms., 24 weeks of treatment.|Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography in kPa) on Imaging., Changes from baseline in liver stiffness measurement by magnetic resonance elastography is measured in both arms (absolute change in kPa from baseline)., 24 weeks of treatment.|Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography) on Imaging., Baseline liver stiffness measurement (LSM) by magnetic resonance elastography (in kPa) in both arms., Baseline measurement of liver stiffness by magnetic resonance elastography is reported in each arm.
|
