A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

For all participants at Week 52, incidence and severity of TEAEs., For all participants at Week 52, incidence and severity of TEAEs leading to discontinuation., For all participants at Week 52, incidence of Grade 3 and Grade 4 laboratory abnormalities.

Absolute and relative change from baseline to Week 52 in ELF score for all participants., Achieving an improvement in ELF score of ≥ 0.5., Absolute and relative change from baseline to Week 52 in VCTE-LSM scores for all participants., Achieving a change from baseline in VCTE-LSM ≥ 30% at Week 52., Absolute and relative change from baseline to Week 52 in the subset of participants with MRE scores., Absolute and relative change from baseline to Week 52 in HFF by MRI-PDFF for all participants., Absolute and relative change from baseline to Week 52 in ALT, AST, and ALT/AST ratio for all participants., Achieving ALT and HFF normalization at Week 52., Achieving HFF ≤ 5% at Week 52., Change from baseline to Week 52 in HbA1c for participants with T2DM., Change from baseline to Week 52 in body weight for all participants., Change from baseline in fasting total cholesterol, LDL-C, HDL-C, and fasting triglycerides at Week 52 for all participants., Incidence of ADAs at Week 52., Efimosfermin serum concentrations in participants with PK data following multiple doses.

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