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Omega-3 carboxylic acid

Phase 2

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

Omega-3 carboxylic acid development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2015

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

Omega-3 carboxylic acid clinical trials

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 (NAFLDUnlock trial analytics

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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Frequently asked questions about Omega-3 carboxylic acid

What is Omega-3 carboxylic acid?

Omega-3 carboxylic acid is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for metabolic disease. It has been studied in non-alcoholic fatty liver disease (NAFLD) and hypertriglyceridemia. Development has reached Phase 2.

What is Omega-3 carboxylic acid used for in NAFLD?

Omega-3 carboxylic acid has been studied for non-alcoholic fatty liver disease (NAFLD) in overweight adults, with a secondary focus on hypertriglyceridemia. The Phase 2 trial evaluated its effect on liver fat. It is investigational and not approved for this use.

Who makes Omega-3 carboxylic acid?

Omega-3 carboxylic acid is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 2 trial of the drug in NAFLD and hypertriglyceridemia.

What phase is Omega-3 carboxylic acid in?

Omega-3 carboxylic acid is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved for any indication.

What clinical trials is Omega-3 carboxylic acid in?

Omega-3 carboxylic acid has been evaluated in one completed Phase 2 trial, NCT02354976. This double-blind, randomized, placebo-controlled study compared Epanova and fenofibrate on liver fat in overweight subjects with NAFLD and hypertriglyceridemia. It enrolled 78 participants in Sweden.

Is Omega-3 carboxylic acid the same as Epanova?

Yes, Omega-3 carboxylic acid is also known as Epanova. The Phase 2 trial NCT02354976 was titled as a comparison of Epanova and fenofibrate on liver fat in overweight subjects, confirming the alternative name.