This Phase II clinical research study is looking for adults 18 years of age and older who have been diagnosed with nonalcoholic steatohepatitis (NASH) and stage 3 or 4 liver fibrosis. The purpose of this study is to evaluate the safety and effectiveness of a study drug in NASH patients with either stage 3 or stage 4 fibrosis. The study drug is an oral tablet that is being investigated to see if it can slow down the inflammation and fibrosis associated with NASH.
Participation in this study consists of 28 study visits over about a two-year period. Individuals will be evaluated to determine their eligibility to participate in this study. Each person who qualifies will, after the placebo-controlled part of the study, receive the study drug, as well as study-related medical exams and study-related laboratory tests, all at no cost.
Your first step with NASH
As you may already know, nonalcoholic steatohepatitis (NASH) is the most severe form of nonalcoholic fatty liver disease (NAFLD) – the most common chronic liver disease in the world. NASH is a serious disease that can progress to chronic liver damage such as advanced fibrosis or cirrhosis, liver failure, or liver cancer. A NASH diagnosis is characterized by NAFLD with steatosis (retaining excess fatty tissue), liver cell injury, liver cell death, and inflammation. Other symptoms include:
• Loss of appetite
• Swelling in the legs
• Slurred speech
• Abdominal discomfort
In most cases, NASH is the consequence of a diet high in fat and sugar and a lack of physical activity. But with lifestyle changes – like healthier eating and exercise – the liver can actually begin to repair itself. But if you've recently been diagnosed with NASH, it can be hard to know what steps to take. Right now, a clinical research study for NASH is underway, and you may be eligible to participate.
For additional information and educational support regarding NASH, please visit one of the following advocacy sites:
• American Liver Foundation
• Fatty Liver Foundation
• Global Liver Institute
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