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

NCT02354976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-09-25

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Lars Lind, Professor · Uppsala University Hospital. Uppsala Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-05-26
Completion
2016-05-26

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02354976 on ClinicalTrials.gov