Non-alcoholic Fatty Liver Disease (NAFLDPhase 2NCT02354976
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
A Phase 2 study testing Omega-3 carboxylic acid and Fenofibrate 200mg in people with Non-alcoholic Fatty Liver Disease (NAFLD and Hypertriglyceridemia, run by AstraZeneca at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
- What is being tested?
- Omega-3 carboxylic acid and Fenofibrate 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Sep 2015to 26 May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Research Site
Gothenburg, 413 45
Research Site
Malmö, 205 02
Research Site
Stockholm, 11324
Research Site
Uppsala, 75237
About this study
Official title: 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
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.
- Being tested
- Placebo, Omega-3 carboxylic acid, Fenofibrate 200mg
- Keywords
- omega-3 carboxylic acid
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo matching to Omega-3 carboxylic acids (olive oil)
Omega-3 carboxylic acidDrug
4 g administered as 4 x 1 g capsules
Fenofibrate 200mgDrug
200mg capsule administered once daily
PlaceboDrug
Placebo matching to fenofibrate 200mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Omega-3 carboxylic acids 4g / day | Experimental | Not described Receives: Drug: Omega-3 carboxylic acid |
| Fenofibrate 200mg | Active comparator | Not described Receives: Drug: Fenofibrate 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start1 Sep 2015
- Primary completion26 May 2016
- Study completion26 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Lind, Professor, Principal investigator, Uppsala University Hospital. Uppsala Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354976
- Sponsor's protocol ID
- D5881C00007
- Status last verified
- Sep 2018
- First submitted
- 30 Jan 2015
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 30197273
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02354976
- Acronym / sponsor ID
- D5881C00007
- Keywords
- omega-3 carboxylic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Omega-3 carboxylic acids 4g / day | Experimental | Drug: Omega-3 carboxylic acid |
| Fenofibrate 200mg | Active comparator | Drug: Fenofibrate 200mg |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo matching to Omega-3 carboxylic acids (olive oil) | Drug | Placebo |
| Omega-3 carboxylic acid4 g administered as 4 x 1 g capsules | Drug | Omega-3 carboxylic acids 4g / day |
| Fenofibrate 200mg200mg capsule administered once daily | Drug | Fenofibrate 200mg |
| PlaceboPlacebo matching to fenofibrate 200mg | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30197273Oscarsson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lind, Professor principal investigator
Uppsala University Hospital. Uppsala Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 carboxylic acid and Fenofibrate 200mg in people with Non-alcoholic Fatty Liver Disease (NAFLD and Hypertriglyceridemia, run by AstraZeneca at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.