Is saroglitazar indicated in Metabolic-Associated Liver Disease (MetALD) causing cirrhosis?

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Last updated: December 24, 2025 • View editorial policy

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Saroglitazar is NOT Indicated for MetALD with Cirrhosis

Saroglitazar cannot be recommended for MetALD causing cirrhosis, as current EASL-EASD-EASO guidelines do not endorse saroglitazar for MASLD-targeted therapy due to lack of large Phase III trials demonstrating histological improvement, and no MASH-targeted pharmacotherapy is currently recommended for the cirrhotic stage. 1, 2

Guideline Position on Saroglitazar

  • The 2024 EASL-EASD-EASO guidelines explicitly state that no MASH-targeted pharmacotherapy can currently be recommended for the cirrhotic stage 1

  • Saroglitazar is not recommended as a MASLD/MASH-targeted therapy because it lacks large Phase III trials demonstrating histological improvement in liver fibrosis or steatohepatitis 2

  • The guidelines prioritize resmetirom for non-cirrhotic MASH with significant fibrosis (stage ≥2), but even this agent is not recommended once cirrhosis develops 1

MetALD-Specific Considerations

  • MetALD is defined as hepatic steatosis with at least one cardiometabolic risk factor plus alcohol consumption of 20-50 g/day in women or 30-60 g/day in men 3

  • MetALD represents a distinct subclass with worse prognosis than MASLD despite identical cardiometabolic risk factor prevalence 3

  • The efficacy of MASH-targeting therapies in individuals with MetALD needs thorough assessment, with focus on liver-related outcomes, as this remains a research priority 1

Recommended Management Approach for MetALD with Cirrhosis

Primary Interventions

  • Alcohol abstinence is essential, as MetALD involves moderate alcohol consumption that contributes to disease progression 4

  • Lifestyle modification including weight loss (7-10% target), Mediterranean diet, and 150-300 minutes weekly of moderate-intensity exercise 2

  • Optimal management of cardiometabolic comorbidities using guideline-recommended agents 1

Pharmacological Options for Metabolic Comorbidities

  • GLP-1 receptor agonists (semaglutide, liraglutide) or dual GIP/GLP-1 agonists (tirzepatide) are preferred for patients with type 2 diabetes or obesity, as they improve cardiometabolic outcomes and are safe in compensated cirrhosis 2

  • SGLT2 inhibitors are safe in MASLD and should be used for approved indications (diabetes, heart failure, chronic kidney disease) 2

  • Metformin should be continued if already prescribed, as it is safe in compensated cirrhosis and may improve transplant-free survival 2

Cirrhosis-Specific Management

  • Management of MASH-related cirrhosis includes adaptations of metabolic drugs, nutritional counseling, surveillance for portal hypertension and hepatocellular carcinoma, and liver transplantation consideration for decompensated cirrhosis 1

Evidence Limitations for Saroglitazar

While observational studies show saroglitazar may improve transaminases, liver stiffness measurements, and controlled attenuation parameter values in NAFLD/MASLD patients including some with compensated cirrhosis 5, 6, 7, 8, these are small, uncontrolled studies that do not meet the evidentiary standards required by current guidelines.

Key Study Findings (Not Guideline-Endorsed)

  • A 2023 Indian study (n=63) showed saroglitazar improved liver stiffness and biochemical parameters in NAFLD patients including 11 with compensated cirrhosis, but this was an uncontrolled observational study 6

  • A 2025 study (n=26) in MASLD with compensated cirrhosis showed minimal changes in liver stiffness over 24 weeks, with only 15.3% showing meaningful regression 8

  • These studies lack the Phase III randomized controlled trial data demonstrating impact on clinical outcomes (mortality, decompensation, liver transplantation, HCC) that guidelines require 1

Off-Guideline Use Considerations

  • Saroglitazar might be considered only when guideline-recommended therapies (GLP-1 agonists, SGLT2 inhibitors) are unavailable, unaffordable, or contraindicated, but this represents off-guideline use based solely on observational data 2

  • Patients must be counseled about the lack of robust evidence for liver-specific outcomes, and transition to guideline-recommended therapies should occur when feasible 2

Common Pitfalls to Avoid

  • Do not delay guideline-recommended metabolic therapies (GLP-1 agonists, SGLT2 inhibitors) in favor of saroglitazar, as these have proven cardiometabolic benefits and safety in compensated cirrhosis 2

  • Do not use saroglitazar as monotherapy without addressing alcohol cessation and lifestyle modification, which remain cornerstones of MetALD management 4

  • Do not assume improvements in transaminases or non-invasive tests translate to improved clinical outcomes without Phase III trial evidence 1

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

2
Guideline

Qualification Criteria for GLP-1 and GIP/GLP-1 Agonists in Hepatosteatosis

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

3
Guideline

Differentiating Metabolic-Associated Fatty Liver Disease (MASLD) and Metabolic-Alcoholic Fatty Liver Disease (MetALD)

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

4
Research

Metabolic Dysfunction and Alcohol-Associated Liver Disease: A Narrative Review.

Clinical and translational gastroenterology, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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