Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)

Prior treatment

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

Other illness

• Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
• Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease \>12.
• Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study

• 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 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
• Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
• MRI-PDFF performed at screening with ≥ 8% steatosis.