Research study for treatment of Fatty Liver

Western States Clinical Research & the physicians of Rocky Mountain Gastroenterology are conducting A phase 3, double-blind, placebo-controlled multicenter study of the effectiveness and safety of an oral investigational study medication in patients with Nonalcoholic Steatohepatitis (NASH).

This is a phase 3 study for patients with NASH (Nonalcoholic Steatohepatitis) who have evidence of liver fibrosis. Participants will remain on the study and continue to receive the study medication or placebo until the study is completed. It is estimated that patients will participate for a minimum of approximately 6 years.

During this time, participants will be evaluated by the study team after the first month of treatment and then once every three months through Month 18. Following the Month 18 visit, participants will be evaluated two times per year (every six-months) for each additional year in the study.

WHAT IS NASH?  NASH is liver inflammation and damage caused by a buildup of fat in the liver. It is an increasingly common chronic liver disease closely associated with diabetes and obesity. NASH is part of a group of conditions called nonalcoholic fatty liver disease (NAFLD) or “fatty liver”.  As NASH progresses it results in liver fibrosis (damaged and scarred liver tissue) which may lead to cirrhosis, liver failure and the need for liver transplantation. Currently, there are no therapies approved for the treatment of NASH. To prevent or slow disease progression, physicians commonly recommend lifestyle changes including diet and exercise.

Symptoms of NASH Usually a silent disease with minimal symptoms: Fatigue, weight loss, and weakness appear in later stages as disease progresses and cirrhosis develops.

Potential complications of NASH may include, but are not limited to:  Fibrosis, Cirrhosis, Insulin resistance, Variceal hemorrhage, Sepsis, Hepatocellular carcinoma, Liver failure

Treatment of NASH  Currently, no therapies are approved for the treatment of NASH.  To prevent disease progression of NASH, physicians recommend:  Lifestyle changes, exercise to reduce body weight, and treatment of other diseases a patient may have such as Type 2 Diabetes.  American Association for the Study of Liver Diseases guidelines recommend vitamin E for first-line therapy in nondiabetic patients with NASH.

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