This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
Age >=18 through <=75 years at enrolment
History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
History or presence of known or suspected MASH with evidence of fibrosis
ALT or AST >=5 × upper limit of normal (ULN)
Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of >=1.3 mg/dL and direct BILI is <=20% of total BILI; 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 Investigator and Study Medical Monitor.
GlaxoSmithKline
Lead sponsor