Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epanova, Epanova® (omega-3 carboxylic acids), Epanova™ QD (2 x 1 g capsules), Crestor
Omega-3 carboxylic acids · 8 trials · 8 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.
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.
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.
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.
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
| 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 |
| 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 |
| 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 | - |
| Omega-3 carboxylic acids 4g / day | EXPERIMENTAL | - |
| Dapagliflozin, 10mg / day | EXPERIMENTAL | - |
| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | 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 |
| 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. |
| 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 |
| CRESTOR | DRUG | - |
| Omacor® (omega-3-acid ethyl esters) | DRUG | 4 g (administered orally as 4 x 1 g capsules) |
| 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 |
| 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 | - |
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 ...
Omega-3 carboxylic acids is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for cardiovascular and metabolic conditions. It has been studied in hypertriglyceridemia and in type 2 diabetes with fatty liver disease of non-alcoholic origin. It is a Phase 3 stage asset and has not been approved by the FDA.
Omega-3 carboxylic acids has been studied for hypertriglyceridemia, where the goal is lowering elevated triglyceride levels, and for type 2 diabetes with fatty liver disease of non-alcoholic origin. The Phase 3 trial in hypertriglyceridemia also enrolled patients with cardiovascular disease. These uses remain investigational and are not approved indications.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of omega-3 carboxylic acids. The company sponsored the clinical program evaluating the drug in hypertriglyceridemia and in type 2 diabetes with non-alcoholic fatty liver disease. No other developer is associated with this asset.
Omega-3 carboxylic acids is in Phase 3 development. The Phase 3 trial, NCT01408303, has completed, and a Phase 2 trial, NCT02279407, has also completed. The drug is investigational and has not been approved by the FDA for any indication.
Two completed trials are registered for omega-3 carboxylic acids. NCT01408303 was a Phase 3, randomized, double-blind, placebo-controlled study of 646 patients with hypertriglyceridemia and cardiovascular disease in the United States. NCT02279407 was a Phase 2 study of 223 patients with type 2 diabetes and non-alcoholic fatty liver disease in Sweden.
Yes. Omega-3 carboxylic acids is also known as omega-3-carboxylic acids and as 2g. These names refer to the same AstraZeneca PLC (AZN) investigational small molecule being studied in hypertriglyceridemia and in type 2 diabetes with fatty liver disease of non-alcoholic origin.