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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
611
Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Percent Change From Baseline in Triglyceride Level at the Final Visit
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.
Time frame: Baseline and 12 weeks
Percent Change From Baseline in Triglyceride Level Over Time
The percentage change between triglycerides collected at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Total Cholesterol Over Time
The percentage change between total cholesterol measured at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time
The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time
The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
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Time frame: Baseline and Weeks 4, 8, 10 and 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time frame: 12 Weeks
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: 12 Weeks
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration
Time frame: 12 Weeks