Approval Probability
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Adjusted LOA
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omefas · 2 trials · 2 indications
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups
The primary endpoints of this study will be the area under the curve (AUC)0-t, AUC0-inf, and maximum concentration (Cmax) of R- and S warfarin and the maximum International Normalized Ratio (INRmax) over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
The INRmax over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| Epanova 2 g | EXPERIMENTAL | - |
| Epanova 3 g | EXPERIMENTAL | - |
| Epanova 4 g | EXPERIMENTAL | - |
| Warfarin and Epanova | EXPERIMENTAL | - |
| Lovaza | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | 4 capsules (1g) daily for 12 weeks |
| omefas | DRUG | 2 capsules (1g) + 2 placebo daily for 12 weeks |
| warfarin | DRUG | A single 25 mg dose of warfarin |
| omega-3-acid ethyl esters | DRUG | 4 x 1 g capsule dose of Lovaza® |
Inclusion Criteria: * Men or women, \>=18 years of age. * Very high serum TG values in the range \>=500 mg/dL and \<2000 mg/dL (\>=5.65 mmol/L and \<22.60 mmol/L) Exclusion Criteria: * Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. * Known lipoprotein lipase im...
Omefas is an investigational small molecule being developed for hypertriglyceridemia and severe hypertriglyceridemia, which are conditions characterized by elevated levels of triglycerides in the blood. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Omefas is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of omefas for the treatment of hypertriglyceridemia and severe hypertriglyceridemia.
Omefas is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied for its potential to treat hypertriglyceridemia and severe hypertriglyceridemia, but further clinical trials are needed to establish its safety and effectiveness.
Omefas has been studied in two completed clinical trials. One trial, NCT01242527, was a Phase 2 study in 399 participants with severe hypertriglyceridemia. Another trial, NCT01431690, was a Phase 1 study in 52 healthy volunteers to assess drug interactions and effects on fatty acid levels. Both trials are completed.
Omefas is also known as Epanova, which is the brand name used in clinical trials. The drug has been studied under the name Epanova in trials such as NCT01242527 and NCT01431690. It is being developed by AstraZeneca for the treatment of hypertriglyceridemia and severe hypertriglyceridemia.