Clinical Trial Search

Primary: Absolute Change in Intrahepatic Lipid Content, by 1H-MRS — -6.6; 3.6 Mean absolute percentage change

Primary: Action on Suspected Advanced Liver Fibrosis — 55; 4 Participants

Primary: Percentage of Liver Fat — -7.9; -4.6 percentage of liver fat — p=0.48

Primary: Change in Hepatic Steatosis — -2.25; -1.3; -5.48; -0.17 liver fat percentage

Primary: Hepatic Insulin Sensitivity Index (HISI) — 0.8; 1.4 [10000/(μmol/min)x(mU/L)] — p=<0.019

Primary: Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6…

Primary: Participants With Normalized Liver Enzyme Levels — 0; 0 Participants

Primary: PAI-1 Level — 151.4; 176.2 ng/mL

Primary: Intrahepatic Lipid Content (IHL, Percent Liver Fat) — 3.9 absolute change in percentage liver fat — p=0.4

Primary: Change in Liver Fat — -3.8; -6.0 percentage of liver fat — p==0.05

Primary: Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 — 8.14; -40.01; -30.14; -40.13 percent change — p=0.0000

Primary: Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16 — -7.2; -17.1; -49.9; -55.9 Percent change

Primary: Hepatic Fatty Acid Oxidation

Primary: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) — 7; 13; 24 Participants

Primary: Change in Hepatic Fat — -10.046; 3.083; -4.013 percentage — p=0.0572

Primary: Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs) — 10; 8; 13; 2 participants

Primary: Insulin Sensitivity — 8 m value — p=<0.05

Primary: Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS) — -8.7; -3.0 percentage decrease from baseline

Primary: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) — 21…

Primary: SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F) — 41; 34; 22; 42 Participants — p==0.061

Primary: Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 — 0.00; -1.68; -2.89 Percentage of liver fat — p=0.3128

Primary: Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) — 25; 18 participants — p=0.34

Primary: Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) — -10.94; -32.62; -41.14…

Primary: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score — -13.0; 8.7 percent change

Primary: Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF — 13.9; 8.4 percentage change in liver fat — p=0.585

Primary: Change in Alanine Aminotransferase (ALT) — -37.8; -14.9 U/L — p=0.0195

Primary: Hematic Levels of Hepatic Enzymes AST — 35.4; 37.5; 31.6; 31.2 IU/L — p=<0.05

Primary: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L — 9; 15; 10 participants — p=0.26

Primary: Percent Change From Baseline in Whole Liver Fat at Week 6 — -7.97; 2.84; -25.43 Percent Change — p=0.1654

Primary: Percent Change From Baseline in Whole Liver Fat at Week 16 — -3.21; -16.12; -4.36 Percent change — p=0.0696