A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis

Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

Time frame: 52 Weeks

Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

Time frame: 52 Weeks

Change from baseline of non-invasive markers of liver fibrosis

ELF (scale of 6.7 to 9.8 when higher scores indicative of increased fibrosis)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of non-invasive markers of liver fibrosis

Pro-C3 (ug/L)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of non-invasive markers of liver fibrosis

Liver stiffness assessed by transient elastography (FibroScan®) (kPa, CAP)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of markers of liver injury

ALT (U/L), AST (U/L), GGT (U/L)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of markers of liver injury

Uric acid (mg/dL)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of lipoproteins

Total cholesterol (mg/dL), TG (mg/dL), Non-HDL-C (mg/dL), HDL-C (mg/dL), and LDL-C (mg/dL)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of markers of insulin sensitivity and glycemic control

HbA1c (%)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of markers of insulin sensitivity and glycemic control

Adiponectin (mg/L)

Time frame: 52 Weeks, 240 Weeks

Change from baseline of body weight (kg)

Time frame: 52 Weeks, 240 Weeks

To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)

Time frame: 52 Weeks, 240 Weeks

To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)

Time frame: 52 Weeks, 240 Weeks

To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)

Time frame: 52 Weeks, 240 Weeks

To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)

Time frame: 52 Weeks, 240 Weeks

To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)

Time frame: 52 Weeks, 240 Weeks