A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
1 other identifier
interventional
78
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2015
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2016
CompletedResults Posted
Study results publicly available
September 25, 2018
CompletedSeptember 25, 2018
September 1, 2018
9 months
January 30, 2015
May 5, 2017
September 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)
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.
Baseline and 12 weeks
Secondary Outcomes (1)
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
12 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATOROmega-3 carboxylic acids 4g / day
EXPERIMENTALFenofibrate 200mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
Research Site
Gothenburg, 413 45, Sweden
Research Site
Malmo, 205 02, Sweden
Research Site
Stockholm, 11324, Sweden
Research Site
Uppsala, 75237, Sweden
Related Publications (1)
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.
PMID: 30197273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Torbjörn Lundström
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Lind, Professor
Uppsala University Hospital. Uppsala Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 3, 2015
Study Start
September 1, 2015
Primary Completion
May 26, 2016
Study Completion
May 26, 2016
Last Updated
September 25, 2018
Results First Posted
September 25, 2018
Record last verified: 2018-09