NCT07495995 Ademetionine 1,4-Butanedisulfonate Hepatocellular Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07495995 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: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07495995 is a hot trial to watch

Hepatocellular Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07495995 is notable because it evaluates Ademetionine 1,4-Butanedisulfonate in a Phase 2 design sponsored by Cedars-Sinai Medical Center. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This study will evaluate the safety, feasibility, and preliminary effects of S-adenosyl-L-methionine (SAMe) compared with placebo in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis. Investigators will assess whether treatment is associated with changes in liver-related clinical measures, biologic markers, and other study outcomes relevant to disease progression. The goal of this study is to generate early data to determine whether SAMe should be studied further as a potential therapeutic strategy in patients with MASLD cirrhosis.

Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment was not reported; study geography in Not reported in the indexed record 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 Prognostic Liver Secretome signature (PLSec) score(Baseline to Month 12) — Prognostic Liver Secretome signature (PLSec) is a continuous serum biomarker score used to assess hepatocellular carcinoma risk. Higher PLSec scores indicate higher hepatocellular carcinoma risk, and lower PLSec scores indicate lower hepatocellular carcinoma risk. The primary analysis compares change from baseline to Month 12 between the SAMe and placebo groups. The protocol does not specify a fixed theoretical minim

Readout outlook and evidence gap

The current protocol points to not reported 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: Ademetionine 1,4-Butanedisulfonate 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: Cedars-Sinai Medical Center is resolved to a normalized organization record in LOS ANGELES 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

NCT07495995 provides a focused lens on Hepatocellular Carcinoma development. Its value will be determined by whether Ademetionine 1,4-Butanedisulfonate can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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