SYSTEMATIC REVIEW article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
This article is part of the Research TopicMetabolic dysfunction and steatotic liver diseaseView all 10 articles
Efficacy and safety of efruxifermin for patients with NASH/MASH:an updated systematic review and meta-analysis
Provisionally accepted
- 1The Third People's Hospital of Mianyang, Mianyang, China
- 2The Affiliated Hospital of Southwest Medical University, Luzhou, China
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Aims: Efruxifermin is a promising treatment for non-alcoholic steatohepatitis (NASH), now referred to as metabolic dysfunction-associated steatohepatitis (MASH). This meta-analysis aims to evaluate the efficacy and safety of efruxifermin in patients with NASH/MASH. Methods: We systematically searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) evaluating the efficacy and safety of efruxifermin in patients with NASH/MASH up to 6 August 2025. The primary outcomes were changes in liver fibrosis and steatosis, with safety assessed through adverse events. Results: This meta-analysis included 4 RCTs with 419 participants. Compared with placebo, efruxifermin significantly increased the proportion of patients with ≥1 stage improvement in liver fibrosis without worsening steatohepatitis (relative risk [RR]: 2.18, 95% confidence interval [CI] [1.34, 3.57], P = 0.002), enhanced NASH/MASH resolution with fibrosis improvement (RR: 5.15, 95% CI [1.52, 17.47], P = 0.009) , and ≥2-point non-alcoholic fatty liver disease activity score (NAS) improvement without fibrosis worsening (RR: 3.34, 95% CI [1.93, 5.80], P < 0.001). Additionally, efruxifermin modestly reduced the enhanced liver fibrosis (ELF) score and liver stiffness measurement (LSM), and significantly decreased serum N-terminal type-III collagen pro-peptide (ProC3) levels. For steatosis reduction, efruxifermin significantly increased the proportions of patients with ≥30% hepatic fat fraction (HFF) reduction (RR: 4.69, 95% CI [2.53, 8.71], P < 0.001), ≥50% HFF reduction (RR: 22.57, 95% CI [5.78, 88.22], P < 0.001), and liver fat normalization (RR: 13.03, 95% CI [3.30, 51.50], P < 0.001). However, the efruxifermin group had higher rates of both adverse events leading to discontinuation and gastrointestinal adverse events. Conclusions: Efruxifermin may represent a promising therapeutic option for NASH/MASH. Given the limitations in both the number and quality of the included RCTs, the conclusions should be interpreted with caution. Further large-scale, multicenter, long-term, and high-quality RCTs are necessary to validate these results in diverse populations.
Keywords: Efruxifermin, NASH, MASH, Fibrosis, steatohepatitis, Meta-analysis
Received: 23 Oct 2025; Accepted: 17 Dec 2025.
Copyright: © 2025 Xiao, Liu, Zhang, Tian, Liu, Cheng, Deng and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Cunliang Deng
Hao Sun
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