NCT07480096 Lemborexant Sleep Initiation and Maintenance Disorders Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07480096 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 NCT07480096 is a hot trial to watch
Sleep Initiation and Maintenance Disorders is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07480096 is notable because it evaluates Lemborexant in a Phase 2 design sponsored by University of Indonesia. 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 | NCT07480096 |
| Official title | Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems |
| Phase / status | Phase 2 / Completed |
| Intervention | Lemborexant |
| Sponsor | University of Indonesia |
| Geography | Indonesia |
| Enrollment | 82 |
| Primary endpoint | Sleep quality |
| Endpoint time frame | From enrollment to the end of treatment at 2 weeks |
| Primary completion / readout proxy | 2025-10-30 |
Protocol design and endpoint interpretation
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.
Allocation is Randomized, masking is Triple, and the intervention model is Crossover Assignment. Planned enrollment of 82 participants across Indonesia 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.
- Sleep quality (From enrollment to the end of treatment at 2 weeks) — PSQI score
Readout outlook and evidence gap
The current protocol points to 2025-10-30 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: Lemborexant 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: University of Indonesia is resolved to a normalized organization record in Indonesia. 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
NCT07480096 provides a focused lens on Sleep Initiation and Maintenance Disorders development. Its value will be determined by whether Lemborexant can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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