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

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ClinicalTrials.gov Identifier: NCT02354976
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease (NAFLD Hypertriglyceridemia Drug: Placebo Drug: Omega-3 carboxylic acid Drug: Fenofibrate 200mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : May 26, 2016
Actual Study Completion Date : May 26, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo matching to Omega-3 carboxylic acids (olive oil)

Drug: Placebo
Placebo matching to fenofibrate 200mg
Experimental: Omega-3 carboxylic acids 4g / day Drug: Omega-3 carboxylic acid
4 g administered as 4 x 1 g capsules
Active Comparator: Fenofibrate 200mg Drug: Fenofibrate 200mg
200mg capsule administered once daily


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) [ Time Frame: Baseline and 12 weeks ]
    To evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.


Secondary Outcome Measures :
  1. Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate) [ Time Frame: 12 weeks ]
    To evaluate the efficacy of Epanova compared to Fenofibrate with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354976


Locations
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Sweden
Research Site
Göteborg, Sweden, 413 45
Research Site
Malmö, Sweden, 205 02
Research Site
Stockholm, Sweden, 11324
Research Site
Uppsala, Sweden, 75237
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Lars Lind, Professor Uppsala University Hospital. Uppsala Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02354976    
Other Study ID Numbers: D5881C00007
First Posted: February 3, 2015    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018
Last Verified: September 2018
Keywords provided by AstraZeneca:
omega-3 carboxylic acid
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Overweight
Hypertriglyceridemia
Overnutrition
Nutrition Disorders
Body Weight
Digestive System Diseases
 Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents