Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epanova · 7 trials · 6 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.
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.
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
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
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
| 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. |
| 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 |
| Rosuvastatin | EXPERIMENTAL | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova® | EXPERIMENTAL | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) |
| Epanova® + Crestor® | EXPERIMENTAL | Epanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 |
| Vascepa® | ACTIVE_COMPARATOR | Vascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). |
| 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) |
| 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 | - |
| rosuvastatin 40 mg tablet | DRUG | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova™ QD (2 x 1 g capsules) | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13) |
| Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose | DRUG | Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24 |
| Multiple (20) oral doses of 2 g Vascepa® every 12 hours | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20). |
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 ...
Epanova is an investigational small molecule being developed for conditions including hypertriglyceridemia, severe hypertriglyceridemia, and as an add-on to statin therapy in patients at high risk for atherosclerotic cardiovascular disease. It has also been studied in type 2 diabetes and healthy subjects. Epanova is not FDA approved and remains in clinical development.
Epanova is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of Epanova across multiple indications, including hypertriglyceridemia and cardiovascular risk reduction.
Epanova is in Phase 2 clinical development. While two Phase 3 trials have been completed, the drug remains investigational and has not received FDA approval. The most recent completed trial was a Phase 2 study in type 2 diabetes patients with pancreatic exocrine insufficiency.
Epanova has been studied in four completed trials. NCT02009865 (EVOLVE II) tested it in hypertriglyceridemia with 379 patients. NCT02104817 evaluated cardiovascular outcomes in 13,078 high-risk patients. NCT02370537 examined its uptake in type 2 diabetes, and NCT02859129 studied interactions with rosuvastatin in healthy volunteers.
Epanova and Omacor are distinct drugs, though they were compared in a clinical trial. NCT02370537 investigated the uptake of a single dose of Epanova or Omacor in patients with different degrees of pancreatic exocrine insufficiency. Both are omega-3-based products, but they are not the same medication.
Epanova is a small molecule developed for metabolic conditions, but its specific molecular target is not disclosed in the available trial information. Clinical studies have focused on its effects on triglyceride levels and cardiovascular risk reduction rather than a defined biological target.