Non-Alcoholic Fatty Liver Disease Clinical Trials

• Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:

‣ Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR

⁃ NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.

• Aspartate aminotransferase (AST) \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.

• Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:

‣ Diagnosis of type 2 diabetes OR

⁃ Presence of 2 or more components of metabolic syndrome:

• Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose

∙ Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension

∙ Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides

∙ Serum high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) in men and \< 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL

∙ Overweight or obese (body mass index \[BMI\] ≥ 25 kg/m2 \[BMI ≥ 23 kg/m2 in Asians\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in Asians).