Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

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, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.

Inclusion criteria

Visit 1 (Week -4)

• Undergoing lifestyle modification.
• Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
• Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
• Outpatient.
• Capable of understanding and complying with protocol requirements.
• Signed a written, informed consent form prior to the initiation of any study procedures.
• A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

Visit 2 (Week -2)

• Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
• Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value

Exclusion criteria

Visit 1 (Week -4)

• Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
• Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
• History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
• Diagnosed with pancreatitis.
• Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
• Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
• Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
• Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
• If female, was pregnant or lactating.
• Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
• Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
• Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
• Received TAK-085 in a clinical study.
• Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

Visit 2 (Week -2)

• ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
• Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
• Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

Visit 3 (Week 0)

• Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
• Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons