Testing Efimosfermin alfa against a placebo for non-alcoholic fatty liver disease

Exclusion

• −Hepatitis B virus (detectable HBsAg at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →);
• −Hepatitis C virus (HCV);
• −Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis or any history or evidence of cirrhosis on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
• −Contraindication or ineligibility for percutaneous liver biopsy
• −ALT or AST \>=5 x upper limit of normal (ULN)
• −Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; otherwise, the individual will be excluded.
• −Serum albumin \<=3.5 grams per deciliter (g/dL)
• −International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and Study Medical Monitor.
• −Alkaline phosphatase (ALP) \>=2\*ULN
• −Platelet (PLT) count \<140,000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor.
• −Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation
• −Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
• −Glycated hemoglobin \>=9.0%
• −Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
• −Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening
• −Evidence of infection with any of the following:
• −Human immunodeficiency virus;
• −Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening