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A Study of the Use of a New Drug in People with Non-Alcoholic Steatohepatitis (NASH) or Non-Alcoholic Fatty Liver Disease

IRB/UVa Tracking #: 20155

Principal Investigator: Basu Rita,

Contact: Pamela Morris

Tel: 4349245780

Email: pm2t@virginia.edu

Study Description

The Department of Endocrinology & Metabolism, Center for Diabetes Technology, seeks adult men and women, ages 21-75, with Non-Alcoholic Steatohepatitis (NASH) or Non-Alcoholic Fatty Liver Disease (NAFLD) for a research study. The purpose of the study is to assess a new drug to decrease liver fat in subjects with NASH or NAFLD. The study involves taking an experimental medication or placebo; day-long temporary IV placements; blood draws; urine specimens; bone scan; additional scans (MRE, MRS) to measure liver tissue ‘stiffness’; and electrocardiogram. Participation in this trial will be approximately five months. During that time, you will be asked to come to UVA for up to eight outpatient visits. The first visit, to determine if you are eligible to participate, will last between three and six hours; additional visits will last between one hour and three hours; there are also two all-day visits beginning between 5 am and 7 am. Study-related exams, tests and experimental medication are provided free of charge.