NCT02354976

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Fatty Liver Disease (NAFLD
• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching to Omega-3 carboxylic acids (olive oil)
DRUG	Omega-3 carboxylic acid	4 g administered as 4 x 1 g capsules
DRUG	Fenofibrate 200mg	200mg capsule administered once daily
DRUG	Placebo	Placebo matching to fenofibrate 200mg

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-26
• Completion: 2016-05-26
• First posted: 2015-02-03
• Last updated: 2018-09-25
• Results posted: 2018-09-25

Locations

4 sites across 1 country: Sweden