Overview

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

Status:
Completed
Trial end date:
2016-05-26
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Fenofibrate
Criteria
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