Supplementary Table 1. Exclusion criteria.

1) Fasting serum TG ＞500 mg/dL at screening

2) Necessity for use of prohibited concomitant medications§ after giving consent and during study period

3) Malabsorption, history of malabsorption, or history of surgical procedures (excluding appendectomy or hernia treatment) that may affect absorption

4) Poorly controlled thyroid disease

5) Poorly controlled diabetes, with HbA1c (NGSP) ≥ 8.0 % at screening

6) Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)

7) AST or ALT exceeding 3 times the upper reference limit at screening

8) Liver cirrhosis or biliary obstruction

9) Complication of malignant tumor or high likelihood of malignant tumor recurrence

10) Provision of 400 mL or more of whole blood within 16 weeks or 200 mL or more of whole blood within 4 weeks prior to the screening test, or of component blood samples (plasma and platelet components) within 2 weeks prior to the screening test

11) History of serious drug allergy (e.g. anaphylactic shock)

12) History of hypersensitivity to pemafibrate or those who have stopped taking pemafibrate for reasons of insufficient efficacy or safety

13) Participation in another clinical trial with administration of medication at the time of giving consent, or administration of any study drug other than placebo within 16 weeks prior to the screening test

14) Otherwise judged by the investigator or other responsible staff as inappropriate for participation in this study

^§From 4 weeks before the screening test to the end of the study: 1) fibrates, 2) corticosteroids (other than topical administration), 3) protease inhibitors, 4) anabolic hormone agents, 5) progestogen. From 12 weeks before the screening test to the end of the study: 6) diabetes drugs (insulin preparation, TZD preparation). From 4 weeks before the start of study drug administration until the end of the study (amiodarone washout prohibited): 7) drugs that moderately or strongly inhibit or induce CYP2C8, 2C9, 3A4, 8) drugs that inhibit P-gp, 9) drugs that inhibit BCRP, 10) drugs that inhibit OCT2, 11) drugs that inhibit OATP1B1, OATP1B3. From the day before administration of the investigational drug to the end of the study: 12) anion-exchange resin (cholestyramine, colestimide).

TG, triglycerides; HbA1c, hemoglobin A1c; NGSP, national glycohemoglobin standardization program; SBP, systolic blood pressure; DBP, diastolic blood pressure; AST, aspartate aminotransferase; ALT, alanine aminotransferase; TZD, thiazolidinediones; CYP, cytochrome P450; P-gp, P-glycoprotein; BCRP, breast cancer resistance protein; OCT, organic cation-transporter; OATP, organic anion-transporting polypeptide.