Table 1. Study endpoints.

Primary endpoint	Secondary endpoints
Efficacy endpoint	Efficacy endpoint	Safety endpoint
Change in ALT level from baseline after 24 weeks of administration	Amount and rate of change in the following parameters: Change in ALT level from baseline after 48 weeks of administration. Changes in hepatic fibrosis markers (fibrosis-4 index, type IV collagen 7s, enhanced liver fibrosisis and Mac-2 binding protein glycosylation isomer) level from baseline after 48 weeks of administration. Amount and rate of change in aspartate aminotransferase, γ-glutamyl transpeptidase, creatinine, blood urea nitrogen, estimated glomerular filtration rate, haemoglobin A1c, platelets, homeostasis model assessment of insulin resistance, HDL-C, non-HDL-C, low-density lipoprotein-cholesterol/HDL-C ratio and triglycerides from baseline after 24 and 48 weeks of administration. (Only for facilities that can perform MRI and US.) Change in liver fat content and liver stiffness from baseline using MRI and US examination. Presence of cardiovascular events, liver disease-related events and carcinogenesis within the intervention and observation period. Change in body weight, body mass index and abdominal circumference from baseline after 24 and 48 weeks of administration. Change in 10-year atherosclerotic cardiovascular disease risk score. Percentage of patients with ALT ≥100 IU/L and/or increased to more than twice the level at baseline.	Occurrence rate of adverse events

ALT, alanine aminotransferase; HDL-C, high-density lipoprotein cholesterol