Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

Inclusion Criteria:

• United States Sites: Adults ≥ 18 to ≤ 70 years.

• Korean Sites: Adults ≥ 19 to ≤ 70 years.

• BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3months prior to screening or since baseline liver biopsy, whichever is earlier.

• Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stageF1-F3) confirmed by liver biopsy within 6 months of Day -7.

• MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria:

• Subjects with a history of active or chronic liver disease, including alcoholicliver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosingcholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1antitrypsin deficiency, human immunodeficiency virus (HIV).

• Any history of clinically significant chronic liver disease including esophagealvarices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization fortreatment of chronic liver disease; or Model for End Stage Liver Disease >12.

• Recent (within 3 months of baseline biopsy) use of therapies associated withdevelopment of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen,aromatase inhibitors, amiodarone, or long-term use of tetracyclines).

• Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, orother therapies not allowed for this study