A double-blind randomized placebo-controlled, parallel-group study during 12 weeks to investigate whether the drugs Epanova® and fenofibrate can influence the liver fat content in patients with overweight.

Phase 1

• Conditions: Patients with overweight and high serum triglyceride levels who have Non-alcoholic fatty liver disease; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003637-26-SE
• Lead Sponsor: AstraZenenca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-23
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 =1.7mM
- Have liver fat content as assessed by MRI >5.5%
- Have a body mass index (BMI) >25 and =40 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 >7.0mM or use of antidiabetic therapy
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
- Elevated NAFLD fibrosis score >0.675
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Tto evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) in overweight patients with no diabetes, at the end of 12 weeks of double blind treatment;Secondary Objective: To evaluate the efficacy of Epanova compared to fenofibrate with respect to reduction in liver fat content (%) in overweight patients with no diabetes, at the end of 12 weeks double blind treatment;Primary end point(s): The difference from baseline to week 12 in liver fat content (%), as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The difference from baseline to week 12 in liver fat content (%), as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment