NCT07581951 HSK-31679 Metabolic Dysfunction Associated Steatohepatitis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07581951 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: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07581951 is a hot trial to watch
Metabolic Dysfunction Associated Steatohepatitis is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07581951 is notable because it evaluates HSK-31679 in a Phase 3 design sponsored by Haisco Pharmaceutical Group Co., Ltd.. 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 | NCT07581951 |
| Official title | A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | HSK-31679 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52. |
| Endpoint time frame | Week 52 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
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.
- Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52. (Week 52) — Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
- Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52. (Week 52) — Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.
- Time to First Occurrence of Disease Progression (Up to 4.5 years) — Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
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: HSK-31679 is indexed as Small molecule drug, with target THR-β, mechanism THR-β agonists, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Haisco Pharmaceutical Group Co., Ltd. is resolved to a normalized organization record in Lhoka, 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
NCT07581951 provides a focused lens on Metabolic Dysfunction Associated Steatohepatitis development. Its value will be determined by whether HSK-31679 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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