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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Non-alcoholic Fatty Liver Disease (NAFLD
Hypertriglyceridemia
Interventions Drug: Placebo
Drug: Omega-3 carboxylic acid
Drug: Fenofibrate 200mg
Enrollment 78
Recruitment Details This study was conducted in 4 centers in Sweden between 01 September 2015 and 26 May 2016.
Pre-assignment Details The study duration was up to 15 weeks, consisting of an initial screening period lasting up to 2 weeks, a 12-week treatment period, and a follow-up telephone call within 1 week after the last dose of study drug. A total of 78 subjects were randomized.
Arm/Group Title Epanova Fenofibrate Placebo
Hide Arm/Group Description Epanova 4 g/day + placebo to Fenofibrate Fenofibrate 200 mg/ day + placebo to Epanova Placebo to Epanova + placebo to Fenofibrate
Period Title: Overall Study
Started 25 27 26
Completed 23 26 23
Not Completed 2 1 3
Reason Not Completed
Other - reason not specified             1             0             1
Study-specifc withdrawal criteria             0             1             0
Adverse Event             1             0             2
Arm/Group Title Epanova Fenofibrate Placebo Total
Hide Arm/Group Description Epanova 4 g/day + placebo to Fenofibrate Fenofibrate 200 mg/ day + placebo to Epanova Placebo to Epanova + placebo to Fenofibrate Total of all reporting groups
Overall Number of Baseline Participants 25 27 26 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 26 participants 78 participants
60.0  (7.79) 61.7  (7.78) 60.8  (7.85) 60.8  (7.73)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 25 participants 27 participants 26 participants 78 participants
<50
3
  12.0%
3
  11.1%
1
   3.8%
7
   9.0%
>=50 - <65
16
  64.0%
14
  51.9%
15
  57.7%
45
  57.7%
>=65
6
  24.0%
10
  37.0%
10
  38.5%
26
  33.3%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 26 participants 78 participants
Female
9
  36.0%
12
  44.4%
12
  46.2%
33
  42.3%
Male
16
  64.0%
15
  55.6%
14
  53.8%
45
  57.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 25 participants 27 participants 26 participants 78 participants
Asian
1
   4.0%
1
   3.7%
0
   0.0%
2
   2.6%
Other
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.3%
White
23
  92.0%
26
  96.3%
26
 100.0%
75
  96.2%
1.Primary Outcome
Title Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all randomized patients, regardless of whether they took study medication or not. In this set, patients were analyzed according to their randomized treatment assignment.
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Epanova 4 g/day + placebo to Fenofibrate
Placebo to Epanova + placebo to Fenofibrate
Overall Number of Participants Analyzed 22 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio of % liver fat
0.98
(0.82 to 1.17)
1.04
(0.95 to 1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.407
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio for difference
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all randomized patients, regardless of whether they took study medication or not. In this set, patients were analyzed according to their randomized treatment assignment.
Arm/Group Title Epanova Fenofibrate
Hide Arm/Group Description:
Epanova 4 g/day + placebo to Fenofibrate
Fenofibrate 200 mg/ day + placebo to Epanova
Overall Number of Participants Analyzed 22 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio of % liver fat
0.98
(0.82 to 1.17)
1.17
(0.99 to 1.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Fenofibrate
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio for difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.70 to 1.02
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epanova Fenofibrate Placebo
Hide Arm/Group Description Epanova 4 g/day + placebo to Fenofibrate Fenofibrate 200 mg/ day + placebo to Epanova Placebo to Epanova + placebo to Fenofibrate
All-Cause Mortality
Epanova Fenofibrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Epanova Fenofibrate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/27 (0.00%)      0/26 (0.00%)    
Infections and infestations       
Urosepsis † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Epanova Fenofibrate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/25 (68.00%)      15/27 (55.56%)      8/26 (30.77%)    
Gastrointestinal disorders       
Abdominal pain † 1  2/25 (8.00%)  2 1/27 (3.70%)  1 2/26 (7.69%)  2
Abdominal pain upper † 1  2/25 (8.00%)  2 0/27 (0.00%)  0 1/26 (3.85%)  1
Diarrhoea † 1  7/25 (28.00%)  7 2/27 (7.41%)  2 4/26 (15.38%)  4
Flatulence † 1  3/25 (12.00%)  3 1/27 (3.70%)  1 1/26 (3.85%)  1
Nausea † 1  3/25 (12.00%)  3 0/27 (0.00%)  0 0/26 (0.00%)  0
Constipation † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Abdominal Distension † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Abdominal tenderness † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Dry mouth † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Eructation † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Faeces discoloured † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Gastritis † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Gastroesophageal reflux disease † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Haematochezia † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Vomiting † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
General disorders       
Fatigue † 1  0/25 (0.00%)  0 2/27 (7.41%)  2 1/26 (3.85%)  1
Pyrexia † 1  0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
Chest pain † 1  0/25 (0.00%)  0 1/27 (3.70%)  2 0/26 (0.00%)  0
Malaise † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Hepatobiliary disorders       
Gallbladder pain † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations       
Nasopharyngitis † 1  2/25 (8.00%)  2 2/27 (7.41%)  2 1/26 (3.85%)  1
Influenza † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Localised infection † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Urinary tract infection † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Vaginal infection † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Injury, poisoning and procedural complications       
Radius fracture † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Metabolism and nutrition disorders       
Hypercholesterolaemia † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  2
Musculoskeletal and connective tissue disorders       
Bone pain † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Muscle spasms † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Myalgia † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders       
Dizziness † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Headache † 1  1/25 (4.00%)  1 1/27 (3.70%)  1 1/26 (3.85%)  1
Renal and urinary disorders       
Bladder pain † 1  1/25 (4.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Cough † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Dysphonia † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry skin † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Petachiae † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Rash † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Urticaria † 1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Surgical and medical procedures       
Tendon operation † 1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Vascular disorders       
Hypertension † 1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Torbjörn Lundström
Organization: AstraZeneca
Phone: 46 317064100
EMail: Torbjorn.lundstrom@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02354976    
Other Study ID Numbers: D5881C00007
First Submitted: January 30, 2015
First Posted: February 3, 2015
Results First Submitted: May 5, 2017
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018