A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.

A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Epanova® Compared to Placebo and Compared to Fenofibrate on Liver Fat Content in Hypertriglyceridemic overwEight subjeCTs; EFFECT I

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia.

Inclusion Criteria: - Provision of informed consent

• Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture

• Have serum triglycerides ≥1.7 mM

• Have liver fat content as assessed by MRI >5.5%

• Have a body mass index (BMI) >25 and ≤40 kg/m2

  , Exclusion Criteria: - History of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

• Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).

• Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

• Total bilirubin >2.0 mg/dL (34.2 µmol/L)

• Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose >7.0 mM or use of antidiabetic therapy

• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. This includes signs of liver disease other than NAFLD that motivates further investigations of treatment based on clinical judgement

• Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to be defined as >14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard liquor) or as judged by the investigator