NCT07517276 Tauroursodeoxycholate sodium 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 NCT07517276 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: 24 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07517276 is a hot trial to watch
Metabolic dysfunction-associated steatotic liver disease is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07517276 is notable because it evaluates Tauroursodeoxycholate sodium in a Phase 2 design sponsored by Peking University First Hospital. 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 | NCT07517276 |
| Official title | TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index (MILK-HI-TUDCA) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Tauroursodeoxycholate sodium |
| Sponsor | Peking University First Hospital |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of maternal treatment-emergent adverse events |
| Endpoint time frame | Baseline to Day 28 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid (TUDCA) in lactating mothers with metabolic dysfunction-associated steatotic liver disease (MASLD). Eligible mother-infant dyads will be screened in the early postpartum period using breast milk bile acid hydrophobicity index. Dyads identified as high risk will be randomized 1:1 to maternal oral TUDCA or placebo. The primary objectives are to assess maternal and infant safety and to evaluate changes in breast milk bile acid hydrophobicity index. Secondary objectives include assessment of infant ketone-related metabolic biomarkers and gut microbiome features. Exploratory outcomes include early infant neurodevelopment during follow-up.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across 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.
- Incidence of maternal treatment-emergent adverse events (Baseline to Day 28) — Number of lactating mothers with treatment-emergent adverse events, serious adverse events, treatment discontinuation, or clinically significant safety findings during the study period.
- Incidence of infant treatment-emergent adverse events (Birth to Day 28) — Number of infants with clinically significant adverse events, feeding intolerance, vomiting, diarrhea, jaundice requiring treatment, hospitalization, or other protocol-defined safety events during follow-up.
- Change in breast milk bile acid hydrophobicity index (Baseline to Day 7) — Change from baseline in breast milk bile acid hydrophobicity index measured by targeted liquid chromatography-mass spectrometry.
Readout outlook and evidence gap
The current protocol points to [object Object] 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: Tauroursodeoxycholate sodium 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: Peking University First Hospital is resolved to a normalized organization record in Beijing Shi, China. 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
NCT07517276 provides a focused lens on Metabolic dysfunction-associated steatotic liver disease development. Its value will be determined by whether Tauroursodeoxycholate sodium can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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