Clinical trial NCT02354976: A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD
Hypertriglyceridemia
Keywords: omega-3 carboxylic acid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Uppsala University Hospital. Uppsala Sweden
name: Lars Lind, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oscarsson J, Onnerhag K, Riserus U, Sunden M, Johansson L, Jansson PA, Moris L, Nilsson PM, Eriksson JW, Lind L. Effects of free omega-3 carboxylic acids and fenofibrate on liver fat content in patients with hypertriglyceridemia and non-alcoholic fatty liver disease: A double-blind, randomized, placebo-controlled study. J Clin Lipidol. 2018 Nov-Dec;12(6):1390-1403.e4. doi: 10.1016/j.jacl.2018.08.003. Epub 2018 Aug 10.