Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02354976 | A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. | PHASE2 | COMPLETED | 78 | — | — | Sep 1, 2015 | May 26, 2016 | Sep 25, 2018 | 4 | Sweden |
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Omega-3 carboxylic acids 4g / day | EXPERIMENTAL | - |
| Fenofibrate 200mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo matching to Omega-3 carboxylic acids (olive oil) |
| Omega-3 carboxylic acid | DRUG | 4 g administered as 4 x 1 g capsules |
| Fenofibrate 200mg | DRUG | 200mg capsule administered once daily |
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...