| Outcome Measures: |
Primary: Number of Treatment-Emergent Adverse Events, The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began., Screening through Week 16 | Secondary: Median MRPDFF at Baseline and Week 12 of Whole Liver, Median MRPDFF at Baseline and Week 12 of Whole Liver. Delineation by a central radiologist of the whole liver in the slice with the largest liver cross-section. The Liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI., Baseline and Week 12 (Visit 8)|Percent Change From Baseline of Median MRPDFF of Whole Liver, The percent change in MR PDFF from baseline to Week 12 of Whole Liver, Baseline and Week 12 (Visit 8)|Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver, Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver at Baseline and Week12. The Whole liver was delineated by a central radiologist. The liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI., Baseline and Week 12|Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver, The percent change from basline in liver fat content as measured by the mean MRI Proton density Fat Fraction (MR PDFF) at baseline and at week 12 of Whole Liver, Screening and Week 12 (Visit 8)|Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3, Median MRPDFF (percentage fat in the liver) of liver segment 3 as measured by MRI Proton Density Fat Fraction at baseline and at week 12. Delineation by a central radiologist of the Liver Segment 3 in the slice with the largest Liver Segment 3 cross-section., Baseline and Week 12 (Visit 8)|Percent Change From Baseline of Median MRPDFF of Liver Segment 3, Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8), Baseline and Week 12 (Visit 8)|Mean MRPDFF of Liver Segment 3, Mean MRPDFF of Liver Segment measured at baseline and Week 12, Baseline and Week 12 (Visit 8)|Percent Change of Mean MRPDFF of Liver Segment 3, Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12, Baseline and Week 12 (Visit 8)|Median MR PDFF of Liver Segment 6, Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 6 in the slice with the largest Liver Segment 6 cross-section., Screening and Week 12 (Visit 8)|Percent Change From Baseline of Median MR PDFF of Liver Segment 6, Percent Change from Baseline of Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12, Screening and Week 12 (Visit 8)|Mean MR PDFF of Liver Segment 6, Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8), Screening and Week 12 (Visit 8)|Percent Change From Baseline of Mean MR PDFF of Liver Segment 6, Percent Change from Baseline Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8), Screening and Week 12 (Visit 8)|Median MRPDFF of Liver Segment 8, Median MRPDFF of Liver Segment 8 measured at baseline and Week 12 (Visit 8), Baseline and Week 12 (Visit 8)|Percent Change in Median MRPDFF of Liver Segment 8, Percent change from baseline in median MRPDFF of Liver segment 8 measured at baseline and week 12 (Visit 8)., Baseline and Week 12 (Visit 8)|Mean MRPDFF of Liver Segment 8, Liver fat percentage of liver segment 8 as measured by MRI Proton Density Fat Fraction (MR PDFF) at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 8 in the slice with the largest Liver Segment 8 cross-section., Baseline and Week 12 (Visit 8)|Percent Change From Baseline in Mean MRPDFF of Liver Segment 8, Percent change from baseline in MRPDFF of liver segment 8 at baseline and at week 12 (Visit 8), Baseline and Week 12 (Visit 8)|Liver Steatosis, Liver steatosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M), Baseline and Week 12 (Visit 8)|Change in Liver Steatosis From Baseline, Change in Liver steatosis from baseline measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M), Baseline and Week 12 (Visit 8)|Liver Fibrosis, Liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa)., Baseline and Week 12 (Visit 8)|Change From Baseline of Liver Fibrosis, The change from baseline in liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa)., Baseline and Week 12 (Visit 8)
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| Locations: |
Orange County Research Center, Tustin, California, 92780, United States|Hadassah Medical Center, Jerusalem, International/Other, Israel|Tel Aviv Sourasky Medical Center- Ichilov Hospital, Tel Aviv, International/Other, 6423906, Israel
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