Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

This is a phase II, double-blinded, placebo-controlled study to investigate the safety,
efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH.
Subjects are required to have a liver biopsy with proven NASH in the 6 month period prior to
screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for
a total of 210 subjects. Subjects will be stratified at randomization by presence or absence
of diabetes. Duration of treatment is 12 months.

Inclusion Criteria:

- Diagnosis of definite NASH

- Patients with diabetes taking stable doses of anti-diabetic agents are eligible

- No significant concomitant medical illness

Exclusion Criteria:

- Diagnosis of cirrhosis.

- Serum ALT > 300 U/L

- Use of drugs associated with steatohepatitis

- Use of the following anit-NASH agents:

1. Vitamin E > 60 IU per day

2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid
(PUFA)-containing supplements > 200 mg per day

3. Thiazolidinediones (e.g. pioglitazone)

- Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase
inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine,
betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF
therapies, or probiotics.

- Other liver disease