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
Track every new NASH/MASH trial automatically
ClinicalTrials.gov updates daily. Our pipeline monitors it and delivers a clean digest every morning.
Start Free: No Credit CardA primary completion date pushed out, enrollment cut, or a primary endpoint changed in the last 90 days. Active trials only.
| Trial | Warning signs | Status |
|---|---|---|
| A Study of INI-822 in Healthy Volunteers and Participants With Metabolic… NCT05945537 | Primary completion moved at least 1 year 4 months later Primary endpoints added | Recruiting |
21 more on the Trials at Risk page. See which trials →
Phase 2 and Phase 3 trials with a primary completion date in the next 180 days, as ClinicalTrials.gov estimates it today. Active trials only.
| Trial | Scheduled | Phase |
|---|---|---|
| Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with… NCT05573204 | Oct 25, 2026 · Estimated | Phase 2 |
15 more on the Completions page. See the calendar →
What 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, 249 recruiting.
Industry sponsors run 94 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 60.
| Top industry sponsor | Active trials |
|---|---|
| Madrigal Pharmaceuticals, Inc. | 8 |
| GlaxoSmithKline (GSK) | 7 |
| Regeneron Pharmaceuticals | 6 |
| Boehringer Ingelheim | 4 |
| Akero Therapeutics, Inc | 3 |
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an… NCT07288138 | Recruiting | Trial sites expanded: 64 → 68 locations | 2026-10-10 |
| MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study NCT07312136 | Enrolling by Invitation | Primary endpoint(s) modified | 2026-10-10 |
| A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in… NCT06903065 | Active, Not Recruiting | Final enrollment: 56 participants (planned 50) | 2026-10-09 |
| A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With… NCT06318169 | Recruiting | Trial sites expanded: 367 → 370 locations | 2026-10-06 |
| A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants… NCT06419374 | Recruiting | Trial sites expanded: 326 → 330 locations | 2026-10-06 |
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 2 trials), the weekly report (top 3 trials). No credit card.
Pro, $49/month or $490/year: 10 sponsor + 10 disease watchlists, 10 saved searches in your email digest, track up to 25 individual trials, full Trials at Risk list, Completions calendar, the full weekly report, landscape reports, CSV export.