| Outcome Measures: |
Number of Participant With Hepatic Histological Improvement in NAS by ??? 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2|Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1|Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2|Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation|Number of Participants With Clinically Significant Changes in Vital Signs|Number of Participants With Clinical Laboratory Abnormalities|Number of Participants With Clinically Abnormal in Electrocardiogram (ECG) Findings|Number of Participants With Hepatic Histological Improvement in NAS at Year 2|Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 1|Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 2|Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-Point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1|Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2|Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1|Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2|Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 1|Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 2|Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (??-SMA) at Year 1|Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (??-SMA) at Year 2|Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 1|Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 2|Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 1|Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 2|Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 1|Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 2|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 3, 6 and 12|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 15, 18 and 24|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 3, 6 and 12|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 15, 18 and 24|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 6 and 12|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 18 and 24|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) at Months 3, 6 and 12|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: NAFLD Fibrosis Score (NFS) at Months 15, 18 and 24|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 6 and 12|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 18 and 24|Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 3, 6 and 12|Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 15, 18 and 24|Change From Baseline in Weight at Months 3, 6 and 12|Change From Baseline in Weight at Months 15, 18 and 24|Change From Baseline in Body Mass Index (BMI) at Months 3, 6 and 12|Change From Baseline in Body Mass Index (BMI) at Months 15, 18 and 24|Change From Baseline in Waist Circumference at Months 3, 6 and 12|Change From Baseline in Waist Circumference at Months 15, 18 and 24|Change From Baseline in Hip Circumference at Months 3, 6 and 12|Change From Baseline in Hip Circumference at Months 15, 18 and 24|Change From Baseline in Forearm Circumference at Months 3, 6 and 12|Change From Baseline in Forearm Circumference at Months 15, 18 and 24|Change From Baseline in Tricep Skinfold Thickness at Months 3, 6 and 12|Change From Baseline in Tricep Skinfold Thickness at Months 15, 18 and 24
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| Locations: |
Dothan, Alabama, United States|Phoenix, Arizona, United States|Tucson, Arizona, United States|Rialto, California, United States|San Diego, California, United States|San Diego, California, United States|San Francisco, California, United States|Littleton, Colorado, United States|Miami, Florida, United States|Tampa, Florida, United States|Chicago, Illinois, United States|Louisville, Kentucky, United States|New Orleans, Louisiana, United States|Baltimore, Maryland, United States|Baltimore, Maryland, United States|Chevy Chase, Maryland, United States|Lutherville, Maryland, United States|Boston, Massachusetts, United States|Worcester, Massachusetts, United States|Ann Arbor, Michigan, United States|Saint Paul, Minnesota, United States|Flowood, Mississippi, United States|Jackson, Mississippi, United States|Tupelo, Mississippi, United States|Buffalo, New York, United States|New York, New York, United States|Durham, North Carolina, United States|Raleigh, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Chattanooga, Tennessee, United States|Germantown, Tennessee, United States|Houston, Texas, United States|Houston, Texas, United States|Live Oak, Texas, United States|San Antonio, Texas, United States|San Antonio, Texas, United States|Salt Lake City, Utah, United States|Richmond, Virginia, United States|Seattle, Washington, United States|Garran, Australian Capital Territory, Australia|Herston, Queensland, Australia|Adelaide, South Australia, Australia|Bedford Park, South Australia, Australia|Clayton, Victoria, Australia|Heidelberg, Victoria, Australia|Melbourne, Victoria, Australia|Perth, Western Australia, Australia|Brussels, Belgium|Brussels, Belgium|Edegem, Belgium|Leuven, Belgium|Angers, France|Lyon cedex 04, France|Montpellier Cedex 5, France|Paris, France|Paris, France|Pessac Cedex, France|Toulouse, France|Vandoeuvre-les Nancy, France|Villejuif, France|Heidelberg, BW, Germany|Marburg, HE, Germany|Hamburg, HH, Germany|Hannover, Niedersachsen, Germany|Aachen, NRW, Germany|Koeln, NRW, Germany|Leipzig, Sachsen, Germany|Leipzig, SN, Germany|Heidelberg, VIC, Germany|Berlin, Germany|Lubeck, Germany|Shatin, New Territories, Hong Kong|Bologna, BO, Italy|Milan, MI, Italy|Rozzano, MI, Italy|Palermo, PA, Italy|Chorzow, Poland|Lodz, Poland|Myslowice, Poland|Rzeszow, Poland|Wroclaw, Poland|Alicante, Spain|Barcelona, Spain|Barcelona, Spain|Barcelona, Spain|Madrid, Spain|Portsmouth, Hampshire, United Kingdom|London, United Kingdom|London, United Kingdom|Newcastle, United Kingdom|Nottingham, United Kingdom
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