Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epanova
omefas · 8 trials · 5 indications
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.
For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).
Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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
Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Cmax: Maximum measured plasma concentration over the time span specified
Area under the plasma concentration versus time curve (AUC0-tau)for simvastatin and beta- hydroxysimvastatin acid, measured over the 24 hour period after the 14th dose
Maximum measured plasma concentration for simvastatin and beta- hydroxysimvastatin acid,during the 0-24 hour dosing interval for the 14th simvastatin dose (Day 14)measured over the 24 hour period after the 14th dose.
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 |
|---|---|---|
| EPANOVA | EXPERIMENTAL | Epanova + statin, once daily |
| Corn oil | ACTIVE_COMPARATOR | Corn oil + Statin |
| Epanova 2 g/day | EXPERIMENTAL | Arm 1 |
| Olive Oil 2 g/day | PLACEBO_COMPARATOR | Arm 2 |
| Sequence AB | EXPERIMENTAL | A single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 7. |
| Sequence BA | EXPERIMENTAL | A single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 7. |
| placebo | PLACEBO_COMPARATOR | - |
| Epanova 2 g | EXPERIMENTAL | - |
| Epanova 3 g | EXPERIMENTAL | - |
| Epanova 4 g | EXPERIMENTAL | - |
| Epanova-Lovaza-Epanova-Lovaza | ACTIVE_COMPARATOR | - |
| Lovaza-Epanova-Lovaza-Epanova | ACTIVE_COMPARATOR | - |
| E4:L4 | ACTIVE_COMPARATOR | Crossover Sequence |
| L4:E4 | ACTIVE_COMPARATOR | Crossover Sequence |
| E2:L4 | ACTIVE_COMPARATOR | Crossover Sequence |
| L4:E2 | ACTIVE_COMPARATOR | Crossover Sequence |
| Epanova and Simvastatin | EXPERIMENTAL | - |
| Simvastatin | ACTIVE_COMPARATOR | - |
| Warfarin and Epanova | EXPERIMENTAL | - |
| Lovaza | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Epanova® (omega-3 carboxylic acids) | DRUG | Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE) |
| corn oil control | DRUG | corn oil control arm |
| Epanova | DRUG | Epanova will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete. |
| Olive Oil | DRUG | Olive oil will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete. |
| Omacor® (omega-3-acid ethyl esters) | DRUG | 4 g (administered orally as 4 x 1 g capsules) |
| placebo | DRUG | 4 capsules (1g) daily for 12 weeks |
| omefas | DRUG | 2 capsules (1g) + 2 placebo daily for 12 weeks |
| Epanova (4 g) and Lovaza (4 g) | DRUG | Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals |
| Lovaza (4 g) and Epanova (4 g) | DRUG | Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose ofEpanova (omefas),4x1g capsules, taken with high-fat meals |
| Lovaza | DRUG | - |
| Simvastatin | DRUG | 40 mg (1 tablet) simvastatin once a day |
| acetylsalicylic acid (ASA) | DRUG | 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin |
| 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: 1. Men or women, ≥18 years of age. 2. Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: 1. LDL-C \<100 mg/dL 2. TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 ...
Omefas is being developed for hypertriglyceridemia, including severe hypertriglyceridemia, a condition marked by elevated triglyceride levels in the blood. It is an investigational small molecule from AstraZeneca PLC and has not been approved for any indication. Clinical work to date has focused on triglyceride lowering in patients with high or very high triglycerides.
Omefas is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the clinical program studying the drug in hypertriglyceridemia and severe hypertriglyceridemia. AstraZeneca is a global biopharmaceutical company headquartered in the United Kingdom.
Omefas is in Phase 1 clinical development. The program includes completed Phase 1 studies in healthy volunteers and a completed Phase 2 study in patients with severe hypertriglyceridemia. No active trials are currently listed, and the drug remains investigational rather than approved.
Omefas has been studied in completed trials including NCT01486433, a Phase 1 drug interaction study with simvastatin in healthy subjects, and NCT01431690, a Phase 1 study examining warfarin interaction and fatty acid levels. A Phase 2 trial, NCT01242527, evaluated triglyceride lowering in severe hypertriglyceridemia across multiple countries.
Across the reported omefas trials, total enrollment was 399 patients. The two Phase 1 studies each enrolled 52 healthy volunteers, while the Phase 2 study in severe hypertriglyceridemia enrolled 399 participants. The Phase 2 trial was randomized and actively controlled, though it was not double blinded.
Omefas is not approved and remains an investigational drug in clinical development. Its trials are listed as completed, with the most advanced being a Phase 2 study in severe hypertriglyceridemia. No regulatory approval has been granted for hypertriglyceridemia or any other indication.