drugset / Trial / NCT02354976

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

NCT02354976 ↗

Phase 2 Completed 78 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

registry analysis (other test); Epanova vs Placebo; p = 0.407; Geometric mean ratio for difference 0.92 (95% CI 0.76 to 1.12); Mixed Models Analysis NCT02354976 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Epanova Other / unclassified 4 g Oral
Comparator Fenofibrate Small molecule 200 mg Oral