Phase 3
N=162
Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT02009865 ↗Enrolled (actual)
162
Serious AEs
1.8%
Results posted
Jan 2016
Primary outcome: Primary: Percent Change in Triglyceride for All Subjects — -28.1; -10.2 Percentage of change (%) — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epanova (Drug); Olive Oil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Triglyceride for All Subjects |
-28.1; -10.2 | 0.017 sig |
| SECONDARY Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL |
-37.5; -9.3 | 0.0008 sig |
| SECONDARY Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL) |
-8.8; 0.4 | 0.0180 sig |
| SECONDARY Percent Change in High-Density Lipoprotein Cholesterol (mg/dL) |
3.4; 3.1 | 0.7117 |
| SECONDARY Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6) |
-24.7; -12.4 | 0.3034 |
Summary
This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.
Eligibility Criteria
Inclusion Criteria
- Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening;
- Willing to use an appropriate and effective method of contraception;
- Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a [repeat measurement]) serum TG ≥500 mg/dL (6 mMol/L) and 4 weeks at screening or is unstable prior to randomization;
- Use of oral or injected corticosteroids or anabolic steroids prior to randomization;
- History of hospitalization for pancreatitis in the last 5 years;
- Uncontrolled diabetes (hemoglobin A1c [HbA1c] >10%);
- Uncontrolled hypothyroidism or thyroid-stimulating hormone (TSH) >5 mIU/L;
- History of cancer (other than basal cell carcinoma) in the past 2 years;
- Cardiovascular event (ie, myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient heart attack, unstable congestive heart failure requiring a change in treatment), revascularization procedure or vascular surgery within 6 months of randomization;
- Use of simvastatin 80 mg or Vytorin 10/80 mg;
- Recent history (within 6 months of randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
- Poorly controlled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN); if ALT/AST is >3 × ULN, the levels have been stable for 3 months and are <5 × ULN;
- Exposure to any investigational product within 4 weeks of randomization; or
- Any condition or therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation in the study not in the subject's best interest.
Data sourced from ClinicalTrials.gov (NCT02009865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.