A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)

Condition studied

Metabolic dysfunction-associated steatohepatitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH

Endpoint detail

Part A: Proportion of participants achieving change from Baseline in vibration controlled transient elastography (VCTE)- liver stiffness measurement (LSM) and in enhanced liver fibrosis (ELF) score, Part A Change from Baseline in VCTE-LSM, Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity, Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity, Part A: Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities