Conditions: Steatohepatitis
Keywords: omega-3 fatty acids alanine transaminase triglycerides lipids EPA ethyl-EPA ethyl icosapentate Non Alcoholic steatohepatitis Non Alcoholic fatty liver disease fatty acids
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 243
Healthy volunteers: no

Brief summary:
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

Detailed description:
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.

Arms:
arm 1: 3x placebo capsules TID arm 2: 2x EPA-E 300 mg capsules + 1placebo capsule TID arm 3: 3x EPA-E 300 mg capsules TID

Interventions: intervention 1: Placebo capsule intervention 2: EPA-E 300 mg capsule intervention 3: EPA-E 300 mg capsule
Intervention descriptions: intervention 1: 3x Placebo capsules three times a day (TID) for 365 days intervention 2: 2x 300 mg capsules + placebo capsule TID for 365 days intervention 3: 3x 300 mg capsules TID for 365 days

Protocol document: