Lead Sponsor

Gannex Pharma Co., Ltd.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

•Age ≥ 18 and ≤ 80 years old at screening.
•Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
•HbA1c ≤ 9.5%.
•Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m\^2

•Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
•History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
•Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of \> 9.5% within 60 days prior to enrollment.
•Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.

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