Clinical Trials for Fatty Liver Disease: NAFLD and NASH Studies

·

Fatty liver disease research has produced its first FDA-approved therapy in 2024 — resmetirom (Rezdiffra) for non-cirrhotic non-alcoholic steatohepatitis (NASH, recently renamed MASH). The approval validated a thyroid hormone receptor beta agonist mechanism and opened a major drug development field after years of failed trials. Multiple agents are in late-stage development for MASLD/MASH (now the preferred terminology). For patients with fatty liver disease, clinical trials for fatty liver offer access to investigational therapies. This guide covers how to find fatty liver trials, active research areas, and resources.

Categories of fatty liver trials

Active MASLD/MASH trials in 2026 include:

Thyroid hormone receptor beta agonists: Beyond resmetirom, additional THR-beta agonists in development.

FGF21 analogs: Pegozafermin, efruxifermin, and others in late-stage development.

GLP-1 receptor agonists: Semaglutide showed benefit in MASH; broader trials testing GLP-1s and dual agonists.

FXR agonists: After obeticholic acid’s challenges, newer FXR agonists with potentially better safety.

SCD1 inhibitors and ACC inhibitors: Targeting de novo lipogenesis.

Cirrhotic MASH trials: Trials specifically in patients who’ve progressed to cirrhosis.

Where to find fatty liver trials

Resources:

  • ClinicalTrials.gov
  • American Association for the Study of Liver Diseases
  • NAFLD Education Initiative
  • Major academic hepatology programs

Diagnosis confirmation for fatty liver trials

Modern fatty liver trials require either liver biopsy or non-invasive markers (FibroScan, MRI-PDFF, ELF score) to confirm diagnosis and stage. Patients considering trial participation often need this evaluation:

  • Liver biopsy: histologic diagnosis with NAS score
  • FibroScan: ultrasound-based fibrosis assessment
  • MRI-PDFF: liver fat quantification
  • Blood-based markers (ELF, FIB-4)

Typical eligibility for fatty liver trials

Common inclusion criteria:

  • Confirmed MASLD or MASH with biopsy or non-invasive markers
  • Specific fibrosis stage (often F2-F3 for non-cirrhotic trials)
  • Adequate liver function

Common exclusion criteria:

  • Other liver diseases (viral hepatitis, autoimmune hepatitis)
  • Significant alcohol use
  • Cirrhosis with decompensation
  • Pregnancy

Frequently Asked Questions

Do I need a liver biopsy to enroll?

Many trials require biopsy confirmation, though non-invasive imaging is increasingly accepted.

Will I get resmetirom in a trial?

Resmetirom is approved and prescribed clinically. Trials test newer agents, combinations, and patients who don’t qualify for resmetirom.

Are GLP-1 trials for fatty liver available?

Yes. GLP-1s and dual agonists show benefit in MASH trials.

What about cirrhotic MASH trials?

Yes, with specific trials for patients who’ve progressed beyond non-cirrhotic disease.

How long do fatty liver trials typically last?

Phase 3 trials are typically 52-72 weeks with potential cardiovascular outcome assessments running longer.

The bottom line on fatty liver trials

Fatty liver research is rapidly expanding after the resmetirom approval validated the field. Multiple novel mechanisms in late-stage development. Major academic hepatology programs provide trial resources. Discuss with your hepatologist or gastroenterologist as part of comprehensive care.

Medical Disclaimer: The information in this article is for educational purposes only and is not intended as medical advice. Always consult with a qualified healthcare professional before making any health-related decisions.

Related Articles