Trial · NCT02354976

A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.

NCT02354976, Phase 2, Completed, AstraZeneca; results first posted 2018-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Trials, record NCT02354976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354976

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
NCT number: NCT02354976
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: AstraZeneca
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
Interventions: Placebo, Omega-3 carboxylic acid, Fenofibrate 200mg, Placebo
First posted: 2015-02-03
Last updated: 2018-09-25
Results first posted: 2018-09-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	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.
Secondary	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	12 weeks	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	Baseline and 12 weeks	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.	ratio of % liver fat	GEOMETRIC_MEAN
SECONDARY	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	12 weeks	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.	ratio of % liver fat	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	Epanova	0.98	95% Confidence Interval 0.82 to 1.17	ratio of % liver fat
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	Placebo	1.04	95% Confidence Interval 0.95 to 1.13	ratio of % liver fat
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	Epanova	0.98	95% Confidence Interval 0.82 to 1.17	ratio of % liver fat
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	Fenofibrate	1.17	95% Confidence Interval 0.99 to 1.37	ratio of % liver fat

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Epanova	25
Overall Study	STARTED	Fenofibrate	27
Overall Study	STARTED	Placebo	26
Overall Study	COMPLETED	Epanova	23
Overall Study	COMPLETED	Fenofibrate	26
Overall Study	COMPLETED	Placebo	23
Overall Study	NOT COMPLETED	Epanova	2
Overall Study	NOT COMPLETED	Fenofibrate	1
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events129

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Epanova	2	25	2
other	Abdominal pain	Gastrointestinal disorders	Fenofibrate	1	27	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	26	2
other	Abdominal pain upper	Gastrointestinal disorders	Epanova	2	25	2
other	Abdominal pain upper	Gastrointestinal disorders	Fenofibrate	0	27	0
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	26	1
other	Diarrhoea	Gastrointestinal disorders	Epanova	7	25	7
other	Diarrhoea	Gastrointestinal disorders	Fenofibrate	2	27	2
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	26	4
other	Flatulence	Gastrointestinal disorders	Epanova	3	25	3

1 to 10 of 129Source ClinicalTrials.gov

See all 129 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Epanova
Total, all-cause mortality	Fenofibrate
Total, all-cause mortality	Placebo
Total, other adverse events	Epanova	17	25
Total, other adverse events	Fenofibrate	15	27
Total, other adverse events	Placebo	8	26
Total, serious adverse events	Epanova	1	25
Total, serious adverse events	Fenofibrate	0	27
Total, serious adverse events	Placebo	0	26

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30197273	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02354976

GET https://conductscience.org/api/trials/v1/NCT02354976/events?page=2

API reference For AI assistants