CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Fenofibrate 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02354976
NCT02354976Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Feb 3, 2015·Updated Sep 25, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo, Omega-3 carboxylic acid, and 1 other intervention for Non-alcoholic Fatty Liver Disease (NAFLD and Hypertriglyceridemia. Completed, enrolled 78 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
CountriesSweden
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartSep 1, 2015
Primary CompletionMay 26, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.4 years ago

Interventions

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