---
title: >-
  Relationship between liver biopsy fibrosis stage and clinical outcomes among
  persons with MASLD/MASH.
description: >-
  Explore this publication on real-world evidence: Relationship between liver
  biopsy fibrosis stage and clinical outcomes among persons with MASLD/MASH..
date: '2024-01-01'
category: Publications
tags:
  - DDG
  - Poster Presentation
  - R&D
  - Care
  - Hepatology
  - MASH/MASLD
  - Pharma Partner
  - Health System Partner
canonical_url: >-
  https://www.pedestalhealth.com/resources/publications/ddg/relationship-between-liver-biopsy-fibrosis-stage-and/
source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: relationship-between-liver-biopsy-fibrosis-stage-and
id: 4toOhvaa0pXdCX28qvtyES
contentType: article
---

## Challenge

Clinical trial sponsors needed real-world evidence confirming that fibrosis stage—as assessed by liver biopsy—is associated with meaningful differences in clinical event rates in the MASLD population, to justify histological improvement as a surrogate endpoint with clinical meaningfulness.

## Solution

The TARGET-NASH cohort was used to analyze clinical outcomes stratified by baseline fibrosis stage and fibrosis trajectory (stable/improving vs. worsening) across paired liver biopsies, quantifying incidence rates of cirrhosis progression, decompensation, HCC, liver transplant, MELD change, cancer, and all-cause mortality.

## Impact

Demonstrating that higher baseline fibrosis and worsening fibrosis trajectory are associated with significantly higher clinical event rates across multiple endpoints validates histological fibrosis as a clinically meaningful surrogate outcome and directly supports the regulatory acceptability of biopsy-based endpoints in MASH trials.

### [Breda Munoz](/people/breda-munoz/)

![Breda Munoz, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/3H1T2mfvSNFj6w9tulnreq/a74ae05fe53e400f176d4e9c617b8fb8/breda-munoz.jpg)

### [Andrea R. Mospan](/people/andrea-mospan/)

![Andrea R. Mospan, PhD, RAC — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/4w6bkwPHPqrXKYs4tHZPkK/1d21763b54ecc3466764986693b7072f/andrea-mospan.jpg)

### [Heather L. Morris](/people/heather-morris/)

![Heather Morris, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/16PnQ817q7tv964vhcUD5f/ce6797c32df11f022ef12ecbb9ffea49/heather-morris.jpg)