Why NASH/MASH trial monitoring matters in 2026
Non-alcoholic steatohepatitis (NASH), recently renamed metabolic dysfunction-associated steatohepatitis (MASH), affects an estimated 6-8% of the global population and is on track to become the leading cause of liver transplantation in the United States. With the 2024 approval of resmetirom (Rezdiffra) as the first-ever approved NASH/MASH treatment, the field has entered a commercial era — and the pipeline is enormous.
The MASH/NASH clinical development landscape in 2026 is one of the most active in gastroenterology:
- THRβ agonists — resmetirom (approved), MGL-3196 follow-ons, and next-generation thyroid receptor-beta agonists for hepatic fat and fibrosis are in development
- GLP-1 receptor agonists — semaglutide (ESSENCE Phase 3 data read out 2023/24), tirzepatide (GIP/GLP-1), and newer GLP-1 agents showing strong MASH activity; combination trials with anti-fibrotic agents proliferating
- FXR agonists — obeticholic acid (OCA) failed Phase 3 for NASH cirrhosis; next-gen FXR agonists (cilofexor, TERN-101) pursuing differentiated profiles
- Anti-fibrotic agents — ASK1 inhibitors, ACC inhibitors, and anti-LOXL2 antibodies pursuing the anti-fibrotic component that GLP-1 agents alone may not fully address
- Combination strategies — two-drug and three-drug combinations pairing metabolic (GLP-1/THRβ) with anti-fibrotic mechanisms are the major Phase 2/3 trend
- NASH-associated HCC prevention — emerging area targeting high-risk cirrhotic patients
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Start Free — No Credit CardWhat we monitor for NASH and metabolic liver disease
Our system pulls from the ClinicalTrials.gov API every day. For a NASH/MASH watch profile, you can configure a saved search for:
- Condition keywords: "NASH", "NAFLD", "MASH", "metabolic dysfunction-associated steatohepatitis", "nonalcoholic steatohepatitis", "liver fibrosis", "metabolic-associated fatty liver"
- Drug/target keywords: "resmetirom", "THRβ", "semaglutide NASH", "tirzepatide liver", "FXR agonist", "obeticholic acid", "GLP-1 NAFLD", "fibrosis F2 F3" — any drug or mechanism you're tracking
- Phase filter: Phase 1 for early combination programs, Phase 2/3 for competitive commercial intelligence
- Sponsor type: Industry, academic, or all
- Status changes: New registrations, enrollment opens, results postings, and terminations
The post-resmetirom MASH pipeline
Resmetirom's approval validated the MASH field commercially and triggered a race to develop differentiated options. The key competitive dynamics:
- GLP-1 combinations are the dominant strategy: Nearly every company is now testing their primary mechanism paired with a GLP-1 agent. Monitoring these combination trial registrations is essential for competitive positioning
- Anti-fibrotic differentiation: Pure metabolic agents reduce fat but may have limited anti-fibrotic effect. Companies with anti-fibrotic mechanisms (anti-LOXL2, anti-TGFβ, Rho kinase inhibitors) are positioning as combination partners
- Advanced fibrosis (F3/F4) vs. earlier disease (F1/F2): Regulatory endpoints differ; monitoring which trials target which fibrosis stage informs the competitive timeline
- Non-invasive biomarkers: Multiple trials are validating FIB-4, ELF score, and imaging biomarkers as trial endpoints — companies that secure surrogate endpoint approval will accelerate development
Who uses NASH/MASH trial monitoring
- Metabolic disease BD teams — tracking competitor programs in GLP-1, THRβ, FXR, and anti-fibrotic categories
- Hepatology and GI investors — monitoring Phase 2/3 initiations and enrollment in the crowded MASH space
- Hepatologists and gastroenterologists — staying current on available trials for patients with advanced fibrosis or MASH cirrhosis
- Diagnostic companies — tracking trials that use non-invasive biomarkers as primary endpoints, validating their technology
- Academic liver disease researchers — following the commercial landscape alongside investigator-initiated programs
Stay ahead of the NASH/MASH clinical pipeline
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Track Free NASH/MASH Trials499 active trials, 248 recruiting.
Industry sponsors run 93 of these trials. The rest are run by universities, hospitals, government bodies and other non-commercial sponsors. The table below lists the 5 largest of 61.
| Top industry sponsor | Active trials |
|---|---|
| GlaxoSmithKline (GSK) | 7 |
| Madrigal Pharmaceuticals, Inc. | 6 |
| Regeneron Pharmaceuticals | 5 |
| Akero Therapeutics, Inc | 3 |
| Boehringer Ingelheim | 3 |
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation NCT05256979 | Active, Not Recruiting | Completion pushed: 2025-06-30 → 2026-11-30 | 2026-09-11 |
| ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult… NCT07334080 | Recruiting | Completion pushed: 2026-05 → 2027-04 | 2026-09-11 |
| InAdvance: Surveillance, Prevention, and Interception in a Population at Risk… NCT05463796 | Recruiting | Completion moved earlier: 2032-03-25 → 2031-03-25 | 2026-08-18 |
| Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and… NCT07390422 | Recruiting | Recruitment opened | 2026-09-16 |
| Study of Resmetirom in Children and Adolescents With MASH NCT07763015 | Recruiting | Recruitment opened | 2026-09-12 |
Each trial page shows every change DataLookout has recorded for that trial.
DataLookout checks ClinicalTrials.gov every day and records what changed on each trial: status, enrollment, phase, primary endpoint, completion dates, sites, sponsor, and the stated reason a trial stopped. Add a sponsor or a disease to your watchlist, or save any search, and the changes arrive in a daily or weekly email digest.
Free, $0 forever: 1 sponsor + 1 disease watchlist, 1 saved search in your email digest, track up to 5 individual trials, daily change detection, Trials at Risk (top trial). No credit card.
Starter, $49/month: 3 sponsor + 3 disease watchlists, 3 saved searches in your email digest, track up to 25 individual trials, full Trials at Risk list and landscape reports.
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