A Phase 2 interventional study of Placebo and Omega-3 carboxylic acid in Non-alcoholic Fatty Liver Disease (NAFLD and Hypertriglyceridemia, sponsored by AstraZeneca. Completed at 4 sites in Sweden. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 78 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Provision of informed consent
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.
Drug: Placebo
Drug: Omega-3 carboxylic acid
Drug: Fenofibrate 200mg
Placebo matching to Omega-3 carboxylic acids (olive oil)
4 g administered as 4 x 1 g capsules
200mg capsule administered once daily
Placebo matching to fenofibrate 200mg
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.
Time frame: Baseline and 12 weeks
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
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
This study was conducted in 4 centers in Sweden between 01 September 2015 and 26 May 2016.
| Milestone | Epanova | Fenofibrate | Placebo |
|---|---|---|---|
| Started | 25 | 27 | 26 |
| Completed | 23 | 26 | 23 |
| Not completed | 2 | 1 | 3 |
| Withdrew: Other - reason not specified | 1 | 0 | 1 |
| Withdrew: Study-specifc withdrawal criteria | 0 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 2 |
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.
| ratio of % liver fat | Epanova | Placebo |
|---|---|---|
| Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) | 0.98 (0.82 to 1.17) | 1.04 (0.95 to 1.13) |
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.
| ratio of % liver fat | Epanova | Fenofibrate |
|---|---|---|
| Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate) | 0.98 (0.82 to 1.17) | 1.17 (0.99 to 1.37) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epanova | — | 1/25 (4%) | 17/25 (68%) |
| Fenofibrate | — | 0/27 (0%) | 15/27 (55.6%) |
| Placebo | — | 0/26 (0%) | 8/26 (30.8%) |
| Event | Epanova | Fenofibrate | Placebo |
|---|---|---|---|
| UrosepsisInfections and infestations | 1/25 | 0/27 | 0/26 |
| Event | Epanova | Fenofibrate | Placebo |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/25 | 2/27 | 4/26 |
| FlatulenceGastrointestinal disorders | 3/25 | 1/27 | 1/26 |
| NauseaGastrointestinal disorders | 3/25 | 0/27 | 0/26 |
| Abdominal painGastrointestinal disorders | 2/25 | 1/27 | 2/26 |
| Abdominal pain upperGastrointestinal disorders | 2/25 | 0/27 | 1/26 |
| NasopharyngitisInfections and infestations | 2/25 | 2/27 | 1/26 |
| FatigueGeneral disorders | 0/25 | 2/27 | 1/26 |
| PyrexiaGeneral disorders | 0/25 | 2/27 | 0/26 |
| ConstipationGastrointestinal disorders | 1/25 | 0/27 | 1/26 |
| Bladder painRenal and urinary disorders | 1/25 | 0/27 | 0/26 |
| Age, Continuous(Years) | Epanova | Fenofibrate | Placebo | Total |
|---|---|---|---|---|
| Mean | 60.0 ± 7.79 | 61.7 ± 7.78 | 60.8 ± 7.85 | 60.8 ± 7.73 |
| Age, Customized(Participants) | Epanova | Fenofibrate | Placebo | Total |
|---|---|---|---|---|
| <50 | 3 | 3 | 1 | 7 |
| >=50 - <65 | 16 | 14 | 15 | 45 |
| >=65 | 6 | 10 | 10 | 26 |
| Sex/Gender, Customized(Participants) | Epanova | Fenofibrate | Placebo | Total |
|---|---|---|---|---|
| Female | 9 | 12 | 12 | 33 |
| Male | 16 | 15 | 14 | 45 |
| Race/Ethnicity, Customized(Participants) | Epanova | Fenofibrate | Placebo | Total |
|---|---|---|---|---|
| Asian | 1 | 1 | 0 | 2 |
| Other | 1 | 0 | 0 | 1 |
| White | 23 | 26 | 26 | 75 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca