NASH, or Nonalcoholic Steatohepatitis, is a common liver disease affecting over 3 million people in the US each year. NASH is characterized by fat deposits in the liver along with inflammation that could potentially result in liver damage. Left to progress, the liver will develop scarring and ultimately lead to cirrhosis, GI bleeding, or liver failure.
Although it resembles alcoholic liver disease, NASH occurs in people who drink little or no alcohol. While the cause of nonalcoholic fatty liver disease is not fully understood, the majority of patients have obesity and/or type 2 diabetes.
In the beginning stages, patients typically display little or no symptoms. As the disease progresses, symptoms such as fatigue, abdominal discomfort, weight loss, and weakness may begin to develop.
Immediate treatment for NASH includes lifestyle changes such as exercise, weight loss, and dietary changes. This is currently the most promising treatment for NASH patients with the hope of stopping the progression of this disease. There are some experimental treatments available aimed at improving or reducing the damage already done to the liver.
Talk with your doctor if you think you may have NASH. There are tests that can be done to determine if you have this disease. If you are interested in a clinical trial aimed at improving NASH, please search our current trials below or speak with your doctor about other available options.
Current Trials for NASH
Title: Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Study Contact: Melanie Dean 615-936-1745 firstname.lastname@example.org
Principal Investigator: Andrew Scanga, MD
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and those with decompensated cirrhosis.
Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week).