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Omega-3 carboxylic acid

Phase 2

Non-alcoholic Fatty Liver Disease (NAFLD | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Sep 25, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

Omega-3 carboxylic acid · 1 trial · 2 indications

Phase 2 1
NCT02354976A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.Non-alcoholic Fatty Liver Disease (NAFLD
COMPLETED78 Analytics
PHASE2COMPLETED
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Non-alcoholic Fatty Liver Disease (NAFLD
NCT0235497678
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Study Endpoints

Primary Endpoints

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 Endpoints

Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Omega-3 carboxylic acids 4g / dayEXPERIMENTAL -
Fenofibrate 200mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGPlacebo matching to Omega-3 carboxylic acids (olive oil)
Omega-3 carboxylic acidDRUG4 g administered as 4 x 1 g capsules
Fenofibrate 200mgDRUG200mg capsule administered once daily
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: - Provision of informed consent * Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture * Have serum triglycerides ≥1.7 mM * Have liver fat content as assessed by MRI \>5.5% * Have a body mass index (BMI) \>25 and ≤40 kg/m2 , Exclus...

Countries:Sweden
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