Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as omega-3-carboxylic acids, 2g, omega-3-carboxylic acids
Omega-3 carboxylic acids · 2 trials · 3 indications
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.
| Arm | Type | Description |
|---|---|---|
| Olive Oil | PLACEBO_COMPARATOR | olive oil: 4 g/day + prescription statin |
| Epanova, 2 g | EXPERIMENTAL | omega-3-carboxylic acids, 2g/day + prescription statin |
| Epanova, 4 g | EXPERIMENTAL | omega-3-carboxylic acids, 4g/day + prescription statin |
| placebo | PLACEBO_COMPARATOR | - |
| Omega-3 carboxylic acids 4g / day | EXPERIMENTAL | - |
| Dapagliflozin, 10mg / day | EXPERIMENTAL | - |
| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Olive oil, 4g | DRUG | Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 2g | DRUG | Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 4g | DRUG | Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin |
| placebo | DRUG | Placebo matching to Omega-3 carboxylic acids (olive oil) |
| Omega-3 carboxylic acids | DRUG | 4 g administered as 4 x 1 g capsules |
| Dapagliflozin | DRUG | 10 mg administered as 10 mg tablet |
Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance t...