A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 611
- Primary Endpoint
- Percent Change From Baseline in Triglyceride Level at the Final Visit
Study Overview
Brief Summary
The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
Detailed Description
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).
This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.
The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
- •Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.
Exclusion Criteria
- •Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
- •Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
- •Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
- •Participants who have been diagnosed with pancreatitis.
- •Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
- •Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
Arms & Interventions
TAK-085 2 g
TAK-085 2 g, orally, once daily for up to 12 weeks.
Intervention: Omega-3-acid ethyl esters 90 (TAK-085) (Drug)
TAK-085 4 g
TAK-085 2 g, orally, twice daily for up to 12 weeks.
Intervention: Omega-3-acid ethyl esters 90 (TAK-085) (Drug)
EPA-E 1.8 g
Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
Intervention: Eicosapentaenoic acid-ethyl (EPA-E) (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Triglyceride Level at the Final Visit
Time Frame: Baseline and 12 weeks
The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.
Secondary Outcomes
- Percent Change From Baseline in Total Cholesterol Over Time(Baseline and Weeks 4, 8, 10 and 12)
- Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time(Baseline and Weeks 4, 8, 10 and 12)
- Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs(12 Weeks)
- Percent Change From Baseline in Triglyceride Level Over Time(Baseline and Weeks 4, 8, 10 and 12)
- Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis(12 Weeks)
- Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time(Baseline and Weeks 4, 8, 10 and 12)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(12 Weeks)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration(12 Weeks)
- Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time(Baseline and Weeks 4, 8, 10 and 12)