NCT07428538 Larsucosterol Alcohol-Associated Hepatitis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Move from a broad disease map to a decision-ready trial dossier. This focused report examines NCT07428538—Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)—using PatSnap Clinical Trials, Drug & Asset, and Company & Deal Intelligence MCP evidence. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 16 July 2026; publication date: 17 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07428538 is a hot trial to watch

Alcohol-Associated Hepatitis is no longer one homogeneous development market. The most consequential programs increasingly compete through a specific mechanism, biomarker, treatment line, delivery strategy or endpoint architecture. NCT07428538 is notable because it tests Larsucosterol in a Phase 3 design with Transplant Free Survival up to Day 90 as a primary decision variable. The wider PatSnap topic query returned 45 trial records and 51 result records, so differentiation depends on evidence quality rather than activity alone.

PatSnap Clinical Trials MCP makes the protocol fields machine-readable, while the companion asset and organization servers add mechanism and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The design should be read as an evidence architecture, not just a phase label. The primary endpoint—Transplant Free Survival up to Day 90—determines what uncertainty this study can resolve. The reported time frame is Up to Day 90. Enrollment of 350 participants and geography in United States shape statistical precision, operational risk and external validity. A strong readout will need to be interpreted against baseline risk, prior treatment, assessment schedule, missing-data handling and the clinical relevance of the observed effect.

Benchmark readouts in the same clinical field

• Aldeyra Therapeutics Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses RASP Product Candidate Pipeline on Next-Generation Molecules (Phase 2): MELD score = Relative to baseline, statistically significant improvement was observed in clinically relevant objective markers of hepatic function and inflammation, including the Model for End-Stage Liver Disease (MELD) score (P=0.001) .
• IL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH) (Phase 2): Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline. = 10 Participants ; Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.: Mean Difference (Net) = 16.7(95% CI, -11.2 to 44.5), P-Value = 0.248; Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.: Mean Difference (Net) = 16.7(95% CI, -11.2 to 44.5), P-Value = 0.248; Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.: Mean Difference (Net) = 16.7(95% CI, -11.2 to 44.5), P-Value = 0.248; Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline. = 14 Participants .
• Effect of terlipressin on patients with hepatorenal syndrome, alcohol-associated hepatitis, and acute-on-chronic liver failure grade 0–2 (Phase 3): HRS reversal = 11.7 % ; HRS reversal = 44.0 % .

These result records are contextual benchmarks rather than direct head-to-head evidence. Cross-trial comparisons can be distorted by population, line of therapy, endpoint definition, follow-up and analysis set. Their value is to clarify what magnitude and type of evidence the market already recognizes.

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Asset and sponsor context

Drug & Asset context: Larsucosterol (Phase 3; DNMTs).

Company & Deal Intelligence context: Bausch Health Americas, Inc. (VRX) — http://www.bauschhealth.com.

The sponsor profile matters because a trial's strategic value depends on more than scientific rationale. 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

1. Sharper patient selection: prospective biomarker definitions that identify who is most likely to benefit.
2. Clinically interpretable endpoints: outcomes that connect biological activity with function, symptoms, survival or treatment burden.
3. Sequencing evidence: randomized data after the most relevant contemporary standard of care.
4. Broader external validity: evidence across additional geographies, demographic groups and real-world care settings.
5. Operational differentiation: a development path that closes the readout gap without sacrificing safety monitoring or durability.

What to monitor next

Monitor recruitment status, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. The most important inflection point is not always the headline data release; a change in endpoint, population or ownership can alter probability of success months earlier.

Bottom line

NCT07428538 is a focused lens on Alcohol-Associated Hepatitis development. Its value will be determined by whether Larsucosterol can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from topic-level benchmark readouts.

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