Resmetirom in Metabolic Dysfunction Associated Steatohepatitis: NCT07680478 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 11 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Not yet recruiting
Recruitment status
120
Planned enrollment
2028-02-28
Primary-completion proxy
Executive view
NCT07680478 evaluates Resmetirom in Metabolic Dysfunction Associated Steatohepatitis. The disclosed sponsor is City University of New York, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is MRI-PDFF change, assessed over Baseline and 12 months.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07680478 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metabolic Dysfunction Associated Steatohepatitis landscape. Drug & Asset MCP drug_fetch was queried for Resmetirom, while Company & Deal Intelligence MCP organization_fetch was queried for City University of New York.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07680478 | Resmetirom | Phase 4 / Not yet recruiting | City University of New York | United States | MRI-PDFF change Baseline and 12 months | 2028-02-28 |
| NCT07718126 | Mazdutide | Phase 2/3 / Not yet recruiting | West China Hospital | China | Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM) From randomization (Week 0) to Week 12 | 2028-08-31 |
| NCT07704892 | Efimosfermin alfa | Phase 3 / Recruiting | GSK Plc | United States | Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH At Week 96 | 2030-10-16 |
| NCT07701993 | Efimosfermin alfa | Phase 3 / Recruiting | GSK Plc | United States, Japan | Time from randomization to an adjudicated composite liver-related clinical outcome From Randomization (Day 1) to Week 356 (end of treatment) | 2033-06-23 |
| NCT07679542 | Artenimol | Phase 1/2 / Recruiting | Third Affiliated Hospital of Nanjing Medical University | China | Change in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF) Baseline (Week 0) to End of Treatment (Week 12) | 2026-06-30 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07680478 is a Phase 4, not yet recruiting study with 120 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “MRI-PDFF change” over “Baseline and 12 months.” The retrieved endpoint description is: Magnetic resonance imaging derived proton-density-fat-fraction (MRI-PDFF) will be used to evaluate liver steatosis. Absolute change in MRI-PDFF (%) between the two groups at month 12, as an indicator for steatosis change.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 120 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Resmetirom as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
4 recent result records were selected as contextual evidence for Metabolic Dysfunction Associated Steatohepatitis. These records do not establish direct evidence for NCT07680478 unless the registration number matches.
Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD
Phase 2; n=35; Pre-Treatment(Mean) = 48 ng/mL (Standard Deviation, 17) Source: https://clinicaltrials.gov/ct2/show/results/NCT04550481
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steato…
Phase 2; n=213; ADR = 10 Participants ; ADR = 8 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05039450
Self-Reported Cognitive Function in Metabolic Dysfunction–associated Steatotic Liver Disease and Metabolic Dysfunction–associated Steatohepatitis: A Post-hoc Analysis of the MAEST…
Phase 2/3; n=2243; Cognitive Function Self-Report score(24-week) = -2.7 Point ( -4.7 to -0.6); Cognitive Function Self-Report score(24-week) = -3.0 Point ( -4.9 to -1.0) Source: https://pubmed.ncbi.nlm.nih.gov/41953252/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
No exact Drug & Asset MCP profile was returned for the protocol wording “Resmetirom.” The report therefore avoids inferring modality, target or global development stage from the name alone.
City University of New York is indexed in United States with the website http://www.cuny.edu. The City University of New York is a public university system offering diverse academic programs and serving various industries. The record lists 19 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Resmetirom is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07680478
Protocol source: https://clinicaltrials.gov/study/NCT07680478
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 11 September 2026.
Resmetirom in Metabolic Dysfunction Associated Steatohepatitis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes MRI-PDFF change and 2028-02-28 the leading decision points.
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