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Area of Science:

  • Hepatology and Gastroenterology
  • Clinical Trial Design
  • Metabolic Diseases

Background:

  • Metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis poses a significant global health challenge, leading to severe complications like liver failure, cancer, and death.
  • The increasing incidence of MASH-related hepatocellular carcinoma (HCC) heightens the demand for liver transplantation.
  • Current Phase 3 trial guidelines for MASH cirrhosis focus on composite endpoints of major adverse liver outcomes (MALO), liver transplantation, and mortality.

Purpose of the Study:

  • To outline optimal strategies for Phase 3 clinical trials in patients with compensated MASH cirrhosis.
  • To identify key patient characteristics and endpoints for improving trial efficiency and success rates.
  • To discuss the potential for accelerated approval based on histological improvements.

Main Methods:

  • Recommends enrolling high-risk patients with MASH cirrhosis defined by clinically significant portal hypertension (CSPH), Child-Turcotte-Pugh A status, and elevated liver stiffness measurements (>6.5 kPa).
  • Advocates for 3-5 years of follow-up and the use of noninvasive criteria for patient enrollment.
  • Suggests incorporating progression to large gastroesophageal varices as an endpoint, which can add 3-5% to the annual event rate.

Main Results:

  • Effect sizes for hard outcomes in metabolic chronic diseases typically range from 0.70-0.85.
  • Event rates in MASH cirrhosis trials can be 3-20% higher in patients with specific risk features.
  • Histologic reversal of cirrhosis (F4 regression) has been achieved within 96 weeks in a Phase 2b trial with efruxifermin, suggesting potential for accelerated approval.

Conclusions:

  • Phase 3 trials for MASH cirrhosis should target high-risk populations and utilize composite endpoints that include major adverse liver outcomes.
  • Strategies to increase regression rates, such as specific liver stiffness measurement limits and platelet thresholds, should be explored.
  • Ongoing trials are investigating novel therapeutics like survodutide, efruxifermin, and resmetirom to address the unmet needs in MASH cirrhosis management.