Trial Outcomes & Findings for A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. (NCT NCT02354976)
NCT ID: NCT02354976
Last Updated: 2018-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-09-25
Participant Flow
This study was conducted in 4 centers in Sweden between 01 September 2015 and 26 May 2016.
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.
Participant milestones
| Measure |
Epanova
Epanova 4 g/day + placebo to Fenofibrate
|
Fenofibrate
Fenofibrate 200 mg/ day + placebo to Epanova
|
Placebo
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
26
|
|
Overall Study
COMPLETED
|
23
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Epanova
Epanova 4 g/day + placebo to Fenofibrate
|
Fenofibrate
Fenofibrate 200 mg/ day + placebo to Epanova
|
Placebo
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|---|
|
Overall Study
Other - reason not specified
|
1
|
0
|
1
|
|
Overall Study
Study-specifc withdrawal criteria
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
Baseline Characteristics
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Baseline characteristics by cohort
| Measure |
Epanova
n=25 Participants
Epanova 4 g/day + placebo to Fenofibrate
|
Fenofibrate
n=27 Participants
Fenofibrate 200 mg/ day + placebo to Epanova
|
Placebo
n=26 Participants
Placebo to Epanova + placebo to Fenofibrate
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 7.78 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
60.8 Years
STANDARD_DEVIATION 7.73 • n=4 Participants
|
|
Age, Customized
<50
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
>=50 - <65
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Customized
>=65
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Epanova
n=22 Participants
Epanova 4 g/day + placebo to Fenofibrate
|
Placebo
n=23 Participants
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|
|
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)
|
0.98 ratio of % liver fat
Interval 0.82 to 1.17
|
1.04 ratio of % liver fat
Interval 0.95 to 1.13
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Epanova
n=22 Participants
Epanova 4 g/day + placebo to Fenofibrate
|
Placebo
n=26 Participants
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|
|
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
|
0.98 ratio of % liver fat
Interval 0.82 to 1.17
|
1.17 ratio of % liver fat
Interval 0.99 to 1.37
|
Adverse Events
Epanova
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Fenofibrate
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epanova
n=25 participants at risk
Epanova 4 g/day + placebo to Fenofibrate
|
Fenofibrate
n=27 participants at risk
Fenofibrate 200 mg/ day + placebo to Epanova
|
Placebo
n=26 participants at risk
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|---|
|
Infections and infestations
Urosepsis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
Other adverse events
| Measure |
Epanova
n=25 participants at risk
Epanova 4 g/day + placebo to Fenofibrate
|
Fenofibrate
n=27 participants at risk
Fenofibrate 200 mg/ day + placebo to Epanova
|
Placebo
n=26 participants at risk
Placebo to Epanova + placebo to Fenofibrate
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.0%
7/25 • Number of events 7
|
7.4%
2/27 • Number of events 2
|
15.4%
4/26 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
3/25 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.0%
3/25 • Number of events 3
|
0.00%
0/27
|
0.00%
0/26
|
|
General disorders
Fatigue
|
0.00%
0/25
|
7.4%
2/27 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/25
|
7.4%
2/27 • Number of events 2
|
0.00%
0/26
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Renal and urinary disorders
Bladder pain
|
4.0%
1/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
General disorders
Chest pain
|
0.00%
0/25
|
3.7%
1/27 • Number of events 2
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Gastrointestinal disorders
Eructation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Gastrointestinal disorders
Haematochezia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Localised infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petachiae
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Surgical and medical procedures
Tendon operation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Vaginal infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place