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.
Parallel
Efimosfermin Alfa
DrugEfimosfermin Alfa will be administered
Placebo
DrugPlacebo will be administered
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Absolute Change from Baseline in enhanced liver fibrosis (ELF) score
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score less than (\<) 9.8: Low risk of progression, ELF score 9.8 to \<11.3: Moderate risk of progression and ELF score greater than or equal to (\>=) 11.3: High risk of progression.
Percent Change from Baseline in ELF score
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score \<9.8: Low risk of progression, ELF score 9.8 to \<11.3: Moderate risk of progression and ELF score \>=11.3: High risk of progression.
Number of participants achieving an improvement in ELF score greater than equal to 0.5
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score \<9.8: Low risk of progression, ELF score 9.8 to \<11.3: Moderate risk of progression and ELF score \>=11.3: High risk of progression.
Absolute Change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) scores
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