The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
Age >=18 and <=75 years at enrollment
History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score >=4 confirmed by a central pathologist
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 enrolled 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)
GlaxoSmithKline
Lead sponsor