Summary
Resmetirom has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in NAFLD / MASH (Metabolic-Associated Steatohepatitis) would be drug repurposing rather than first-in-human development. This does not mean it is approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis). ClinicalTrials.gov lists 4 registered trials linking Resmetirom to NAFLD / MASH (Metabolic-Associated Steatohepatitis): 3 are currently recruiting; 1 is active or not yet recruiting. The most advanced is Phase 4 (NCT07249788). It plans or enrolled 165 participants. Registration activity spans 2025 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2024 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Metabolic Dysfunction-Associated Steatohepatitis ranks 292 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: MASH (formerly NASH) with fibrosis progresses to cirrhosis in ~20% over 10 years on standard care (which until 2024 was lifestyle modification only); fibrosis regression occurs spontaneously in ~25% over 5 years with sustained weight loss.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 66.0 (trials 16.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 3 recruiting, 1 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT07680478 | Nutrition Intervention Combined With Resmetirom for MASH 2026 | not yet recruiting | Phase 4 | 120 |
| NCT07249788 | Resmiterom Efficacy & Safety in Patients With MASH 2025 | recruiting | Phase 4 | 165 |
| NCT07335601 | Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH 2025 | recruiting | Phase 2 | 120 |
| NCT07541469 | Rezdiffra Pregnancy and Lactation Registry 2026 | recruiting | Not applicable | 10 |
Published literature
- Clinical trial publication Improvement in health-related quality of life after treatment with resmetirom in patients with the spectrum of MASLD: From early MASH to MASH cirrhosisYounossi ZM, Nader F, Labriola D et al. · Hepatology communications · 2026 · PMID 41758054
- Cochrane review The Role of Race and Ethnicity in the Response to Metabolic Dysfunction-Associated Steatotic Liver Disease Treatment: A ReviewLaurence A, Gandhi SM, Nylen ES et al. · Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2026 · PMID 41720343
- Cochrane review Divergent effect of diabetes on fibrosis response to semaglutide and resmetirom in noncirrhotic MASH: A meta-analysis of randomized trialsMusso G, Pinach S, Cassader M et al. · Med (New York, N.Y.) · 2026 · PMID 41610839
- Cochrane review Meta-analysis of clinically available pharmacotherapy of biopsy confirmed metabolic dysfunction associated steatohepatitis (MASH)Wood E, Akande R, Iqbal I et al. · Diabetes, obesity & metabolism · 2026 · PMID 41365848
- Clinical trial publication Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH TrialNoureddin M, Rinella M, Taub R et al. · Alimentary pharmacology & therapeutics · 2025 · PMID 41127972
- Clinical trial publication Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosisYounossi ZM, Stepanova M, Racila A et al. · Hepatology (Baltimore, Md.) · 2025 · PMID 39250515
- Clinical trial publication Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled studyHarrison SA, Browne SK, Suschak JJ et al. · Journal of hepatology · 2025 · PMID 39002641
- Cochrane review Clinical Assessment of Common Medications for Nonalcoholic Fatty Liver Disease: A Systematic Review and Bayesian Network Meta-AnalysisShi R, Chai K, Wang H et al. · Journal of evidence-based medicine · 2025 · PMID 39963857
- Cochrane review Efficacy and safety of resmetirom in MASLD and MASH: network meta-analysis of randomized clinical trialsAyesh H, Beran A, Suhail S et al. · Journal of basic and clinical physiology and pharmacology · 2025 · PMID 39780757
- Meta-analysis Development of a cross-species model to predict clinical outcomes based on efficacy in mouse models of non-alcoholic fatty liver diseaseZhu H, Yu J, Luo J et al. · Clinics and research in hepatology and gastroenterology · 2025 · PMID 41033600
- Meta-analysis Comparative efficacy and safety of pharmacologic therapies for metabolic dysfunction-associated steatotic liver disease over 24 weeks in reducing liver steatosis and fibrosis: A network meta-analysisZhong J, Cai Z, Zhu G et al. · Diabetes, obesity & metabolism · 2025 · PMID 40211469
- Meta-analysis A Markov Model Unveiling the Impact of Resmetirom on the Natural History of MASLD Patients: A Sistematic Review and Meta-AnalysisPennisi G, Di Maria G, Enea M et al. · Liver international : official journal of the International Association for the Study of the Liver · 2025 · PMID 40066918
- Systematic review Efficacy and safety of resmetirom for the treatment of nonalcoholic steatohepatitis: a GRADE assessed systematic review and meta-analysisTalha M, Ali MH, Nadeem ZA et al. · European journal of gastroenterology & hepatology · 2025 · PMID 39589833
- Clinical trial publication A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver FibrosisHarrison SA, Bedossa P, Guy CD et al. · The New England journal of medicine · 2024 · PMID 38324483
- Systematic review Role of Resmetirom, a Liver-Directed, Thyroid Hormone Receptor Beta-Selective Agonist, in Managing Nonalcoholic Steatohepatitis: A Systematic Review and Meta-AnalysisDutta D, Kamrul-Hasan ABM, Mondal E et al. · Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2024 · PMID 38697306
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Resmetirom approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
Resmetirom has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in NAFLD / MASH (Metabolic-Associated Steatohepatitis) would be drug repurposing rather than first-in-human development. This does not mean it is approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Resmetirom in clinical trials for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
ClinicalTrials.gov lists 4 registered trials linking Resmetirom to NAFLD / MASH (Metabolic-Associated Steatohepatitis): 3 are currently recruiting; 1 is active or not yet recruiting. The most advanced is Phase 4 (NCT07249788). It plans or enrolled 165 participants. Registration activity spans 2025 to 2026.
What does the evidence show for Resmetirom in NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
Trials of Resmetirom in NAFLD / MASH (Metabolic-Associated Steatohepatitis) are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.