[Editorial] Accelerating MASH trials: from biopsy to biomarkers

After years of near stasis, efforts to develop medical therapies for metabolic dysfunction-associated steatohepatitis (MASH) seem to have passed a genuine inflection point. Two drugs—resmetirom and semaglutide—have received accelerated approval from the US Food and Drug Administration (FDA) for treating MASH with F2–F3 fibrosis, each on the basis of phase 3 trials using histological endpoints. The next significant shift in the field could be in how the trials themselves are designed. In August, 2025, the FDA announced it had accepted a Letter of Intent from Echosens to begin qualifying liver stiffness measured by vibration-controlled transient elastography (VCTE) as the first non-invasive surrogate outcome measure for MASH drug development.