Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epanova
AZD0585 · 6 trials · 5 indications
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
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.
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 |
|---|---|---|
| AZD0585 2g group | EXPERIMENTAL | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| AZD0585 4g group | EXPERIMENTAL | AZD0585 1g × 4 capsules once daily |
| Placebo control group | PLACEBO_COMPARATOR | AZD0585 placebo 1g × 4 capsules once daily |
| 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 |
| Name | Type | Description |
|---|---|---|
| AZD0585 | DRUG | 1g soft capsule |
| AZD0585 placebo | DRUG | 1g soft capsule |
| 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 | - |
Key Inclusion Criteria: * Japanese men or women, ≥20 years of age. * Subjects must meet all of the following criteria; 1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL 2. %TG change between Visit 2 and Visit 3 must be within 30% 3. %LDL-C cha...
AZD0585 is an investigational small molecule being developed for hypertriglyceridemia, a metabolic condition marked by elevated triglyceride levels in the blood. It is in Phase 3 clinical development and has not been approved for any indication. AstraZeneca PLC is the developer.
AZD0585 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 3 clinical program evaluating the drug in hypertriglyceridemia.
AZD0585 is in Phase 3 clinical development for hypertriglyceridemia. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
AZD0585 has been studied in one Phase 3 trial, NCT02463071, titled AZD0585 Phase III Long-term Study in Japan. The trial enrolled 383 participants with hypertriglyceridemia in Japan, was randomized, double-blind, and placebo-controlled, and has completed.
AZD0585 is a small molecule therapeutic candidate. No molecular target or target class information is available for this asset, so its specific mechanism of action cannot be described.