NCT07677384 HS-10506 Sleep Initiation and Maintenance Disorders Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07677384—A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07677384 is a hot trial to watch
Sleep Initiation and Maintenance Disorders is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07677384 is notable because it evaluates HS-10506 in a Phase 3 design while An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07677384 |
| Official title | A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | HS-10506 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
| Collaborators | Not reported |
| Geography | Not reported |
| Enrollment | 600 |
| Primary endpoint | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Endpoint time frame | From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 600 participants across Not reported 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.
- Primary: An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. (From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months)
- Primary: An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participants and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months)
- Primary: An AESI (serious or non-serious) is any medical event specific to the investigational product or clinical trial. (From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months)
- Secondary: Hematology tests will include hemoglobin, hematocrit, red blood cell count, platelets, white blood cell count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Any clinically significant change in hematological values will be determined at the investigator's discretion (Baseline, Week 12, Week 24, Week 36, Week 48)
- Secondary: Clinical chemistry tests will include total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, albumin, total protein, creatinine, glucose, hemoglobin A1c (HbA1c), creatinine kinase. Any clinically significant change in clinical chemistry values will be determined at the investigator's discretion. (Baseline, Week 12, Week 24, Week 36, Week 48)
Benchmark readouts in the surrounding field
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
- A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
- A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: HS-10506 (Phase 3; OX2R)
Company & Deal Intelligence context: Jiangsu Hansoh Pharmaceutical Group Co., Ltd. — China — http://www.hansoh.cn
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 decide 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.
- Sequencing evidence: comparative data after the most 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 probability of success before a headline data release.
Bottom line
NCT07677384 is a focused lens on Sleep Initiation and Maintenance Disorders development. Its value will be determined by whether HS-10506 can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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