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Related Experiment Video

Updated: Jan 9, 2026

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Expert Delphi Consensus on Surrogate Endpoints for Treatment Assessment in Metabolic Dysfunction-associated

Arun J Sanyal1, Atsushi Nakajima2, Elisabetta Bugianesi3

  • 1Virginia Commonwealth University, Richmond, Virginia.

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
|December 8, 2025
PubMed
Summary

Experts reached consensus on key measures for evaluating metabolic dysfunction-associated steatohepatitis (MASH) treatments. Histological endpoints are favored for regulatory approval, while noninvasive tests, like liver stiffness measurement (LSM), are preferred for clinical practice and disease monitoring.

Keywords:
Delphi ConsensusMASHNoninvasive TestsSurrogate EndpointsTreatment Efficacy

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Area of Science:

  • Hepatology
  • Gastroenterology
  • Clinical Trial Design

Background:

  • Metabolic dysfunction-associated steatohepatitis (MASH) presents a growing global health challenge.
  • The need for effective MASH therapies necessitates standardized surrogate endpoints for evaluation.
  • Current consensus on optimal endpoints for regulatory approval, clinical practice, and reimbursement is limited.

Purpose of the Study:

  • To establish expert consensus on appropriate surrogate endpoints for MASH treatment evaluation.
  • To identify suitable surrogate outcome measures for MASH in regulatory, reimbursement, and clinical settings.

Main Methods:

  • A modified Delphi process involving 23 international experts in hepatology and gastroenterology.
  • Two rounds of structured surveys informed by a targeted literature review.
  • Consensus defined as ≥75% agreement, reported following CREDES guidelines.

Main Results:

  • Histological endpoints (fibrosis improvement or MASH resolution) were deemed appropriate for regulatory/reimbursement settings.
  • Noninvasive tests (NITs) are preferred for MASH monitoring in clinical practice.
  • Consensus supported a ≥30% reduction in liver stiffness measurement (LSM) via VCTE or MRE as a meaningful treatment response indicator, supporting replacement of liver biopsy in practice.

Conclusions:

  • Histological and NIT-based measures are crucial for MASH treatment evaluation.
  • A shift towards using NITs, particularly LSM via VCTE or MRE, for routine MASH monitoring is supported.
  • Findings have implications for MASH clinical trial design, reimbursement policies, and clinical guidelines.