NCT07459504 Amino Acids Metabolic dysfunction-associated steatotic liver disease Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07459504 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07459504 is a hot trial to watch
Metabolic dysfunction-associated steatotic liver disease is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07459504 is notable because it evaluates Amino Acids in a Phase 2 design sponsored by Michigan State University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07459504 |
| Official title | SMART Diets for MASLD |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Amino Acids |
| Sponsor | Michigan State University |
| Geography | United States |
| Enrollment | 102 |
| Primary endpoint | Change in hepatic steatosis |
| Endpoint time frame | Baseline to 24 weeks |
| Primary completion / readout proxy | 2029-12-26 |
Protocol design and endpoint interpretation
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
Allocation is Randomized, masking is Single, and the intervention model is Sequential Assignment. Planned enrollment of 102 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change in hepatic steatosis (Baseline to 24 weeks) — Change in hepatic steatosis by magnetic resonance imaging (MRI)
Readout outlook and evidence gap
The current protocol points to 2029-12-26 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Amino Acids is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Michigan State University is resolved to a normalized organization record in CLINTON COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07459504 provides a focused lens on Metabolic dysfunction-associated steatotic liver disease development. Its value will be determined by whether Amino Acids can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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