| Outcome Measures: |
Primary: Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days), Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms, Baseline|Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days), Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms, Baseline to 24 weeks (±7days) | Secondary: Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms, Change from baseline at Week 24 (±7days) is defined as \[(Baseline CAP value) - (Follow-up CAP value)\] / (Baseline CAP value) \* 100 (%), 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline HbA1c at week 24 (±7days) within and between arms, Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline Insulin at week 24 (±7days) within and between arms, Change from baseline at Week 24 (±7days) is defined as insulin at Week 24 (±7days) minus insulin at Week 0, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms, Change from baseline at Week 24 (±7days) is defined as lipid profile (total cholesterol, HDL, LDL, TG) at Week 24 (±7days) minus lipid profile at Week 0, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline AST/ALT at week 24 (±7days) within and between arms, Change form baseline at Week 24 (±7days) is defined as the proportion of AST/ALT values who are normalized at Week 24 (±7days), 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline Body weight at week 24 (±7days) within and between arms, Change from baseline at Week 24 (±7days) is defined as body weight at Week 24 minus body weight at Week 0, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms, Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms, Compare between baseline at Week 24 (±7days) is defined as the occurrence rate of adverse events and drug interruptions or changes, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms, Prediction Factor Analysis of the Improvement of Liver fibrosis after 24 (±7days) weeks compared to Baseline within and between arms, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms, Prediction Factor Analysis of the Improvement of Fatty liver after 24 weeks (±7days) compared to Baseline within and between arms, 1) Baseline, 2) Baseline to 24 weeks (±7days)|Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms, Prediction Factor Analysis of the Improvement of HbA1c after 24 weeks (±7days) compared to Baseline within and between arms, 1) Baseline, 2) Baseline to 24 weeks (±7days)
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| Locations: |
Gangnam Severance Hospital, Seoul, Korea, Republic of|Samsung Hospital, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|Yonsei Severance Hospital, Seoul, Korea, Republic of
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