Supplementary Table 2. Eligibility criteria.
Inclusion criteria | Patients who met all of the following criteria were included in this study: |
1. Patients with fasting TG levels ≥ 150 mg/dL and <500 mg/dL within 12 weeks prior to the provision of their consent | |
2. Patients diagnosed with steatosis by abdominal ultrasound within 6 months prior to the provision of their consent | |
3. Male patients with ALT levels >40 IU/L or female patients with ALT levels >30 IU/L within 12 weeks prior to the provision of their consent | |
4. Male and female patients aged ≥ 20 years | |
5. Patients who provided written informed consent | |
Exclusion criteria | Patients who met any of the following criteria were excluded from this study: |
1. Patients with ALT levels ≥ 250 IU/L | |
2. Patients who were deemed to be excessive drinkers (ethanol intake of ≥ 210 g/week for male patients or ≥ 140 g/week for female patients) | |
3. Patients who used fibrates within 12 weeks prior to the provision of their consent | |
4. Patients who used omega-3 fatty acid agents or relevant supplements within 6 months prior to the provision of their consent | |
5. Patients who used drugs prohibited in this study (e.g., pioglitazone, vitamin E, SGLT2 inhibitors, GLP-1 receptor antagonists, study agent, control agent, or any drug/supplement with the same indications) within 12 weeks prior to the provision of their consent | |
6. Patients with BMI of <22 kg/m2 | |
7. Patients showing unstable glycemic control (HbA1c of 8% or higher within 12 weeks prior to the provision of their consent) | |
8. Patients with cirrhosis | |
9. Patients with plasma creatinine levels ≥ 1.5 mg/dL | |
10. Patients with cholelithiasis or biliary obstruction | |
11. Patients who had chronic liver diseases with any of the following steatosis except for NAFLD: | |
(i) Viral hepatitis (hepatitis B, hepatitis C) | |
(ii) Autoimmune hepatitis | |
(iii) Primary biliary cholangitis | |
(iv) Primary sclerosing cholangitis | |
(v) Drug-induced liver injury | |
(vi) Endocrine/metabolic hepatitis (hyperthyroidism, Wilson disease, hemochromatosis, or alpha-1 antitrypsin deficiency) | |
12. Patients who had a malignant tumor or who were expected to experience recurrence of a malignant tumor after amelioration | |
13. Patients who underwent blood collection or blood donation of ≥ 200 mL within 12 weeks prior to the provision of their consent | |
14. Patients with a history of severe drug hypersensitivity (e.g., anaphylactic shock) | |
15. Patients who were breastfeeding, pregnant, possibly pregnant, or planning to be pregnant | |
16. Patients who were participating in other interventional trials | |
17. Patients who had a history of hypersensitivity to or had contraindications to the study agent or control agent in this study | |
18. Patients who required a legal representative for the provision of consent | |
19. Patients who were considered to be unsuitable for study participation by the investigators |
TG, triglyceride; ALT, alanine aminotransferase; SGLT2, sodium-glucose cotransporter 2; GLP-1, glucagon-
like peptide 1; BMI, body mass index; NAFLD, non-alcoholic fatty liver disease.