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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease (NAFLD Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching to Omega-3 carboxylic acids (olive oil)

Placebo

Intervention Type DRUG

Placebo matching to fenofibrate 200mg

Omega-3 carboxylic acids 4g / day

Group Type EXPERIMENTAL

Omega-3 carboxylic acid

Intervention Type DRUG

4 g administered as 4 x 1 g capsules

Fenofibrate 200mg

Group Type ACTIVE_COMPARATOR

Fenofibrate 200mg

Intervention Type DRUG

200mg capsule administered once daily

Interventions

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Placebo

Placebo matching to Omega-3 carboxylic acids (olive oil)

Intervention Type DRUG

Omega-3 carboxylic acid

4 g administered as 4 x 1 g capsules

Intervention Type DRUG

Fenofibrate 200mg

200mg capsule administered once daily

Intervention Type DRUG

Placebo

Placebo matching to fenofibrate 200mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No