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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

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 3, 2015
Results First Submitted Date  ICMJE May 5, 2017
Results First Posted Date  ICMJE September 25, 2018
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE September 1, 2015
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)		 Difference from baseline to week 12 in the % liver fat content as measured by MRI. [ Time Frame: 12 weeks ]
To evaluate the efficacy of Omega-3 carboxylic acids as compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)		 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)		 Difference from baseline to week 12 in the % liver fat content as measured by MRI. [ Time Frame: 12 weeks ]
To evaluate the efficacy ofOmega-3 carboxylic acid as compared to fenofibrate with respect to reduction in liver fat content (%) at the end of 12 weeks treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-alcoholic Fatty Liver Disease (NAFLD
  • Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Placebo
    Placebo matching to Omega-3 carboxylic acids (olive oil)
  • Drug: Omega-3 carboxylic acid
    4 g administered as 4 x 1 g capsules
  • Drug: Fenofibrate 200mg
    200mg capsule administered once daily
  • Drug: Placebo
    Placebo matching to fenofibrate 200mg
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: Omega-3 carboxylic acids 4g / day
    Intervention: Drug: Omega-3 carboxylic acid
  • Active Comparator: Fenofibrate 200mg
    Intervention: Drug: Fenofibrate 200mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2018)		 78
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2015)		 75
Actual Study Completion Date  ICMJE May 26, 2016
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02354976
Other Study ID Numbers  ICMJE D5881C00007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Lind, Professor Uppsala University Hospital. Uppsala Sweden
PRS Account AstraZeneca
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP