Insomnia DisorderPhase 3NCT07677384
A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder
A Phase 3 study testing HS-10506 in people with Insomnia Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- HS-10506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2026to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);
- Participants are required to voluntarily sign the informed consent form;
- Body mass index (BMI): BMI (weight/height2 [kg/m2]) must be in the range of 18 to 35 kg/m2 (inclusive);
- For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;
- For new Participants: Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
- For new Participants: Participants must have Insomnia Severity Index (ISI) scores≥15 at screening;
- For new Participants: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST<6.5 hours for at least three nights every week within one month prior to screening; and sSOL≥30 minutes, sWASO≥30 minutes, and sTST<6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before the first dose in the open-label treatment period;
Who cannot join
- Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;
- Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;
- Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single/multi-target drugs within the past 2 weeks or 5 half-lives of the medication;
- Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;
- Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;
- Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;
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- Has a history of smoking≥10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;
- Has a history of caffeine consumption≥600 mg per day or can't obey the rules of caffeine restriction;
- Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;
- Has taken more than 3 naps per week for>1 hour each time within the past 2 weeks prior to screening;
- Has any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
- For Participants completed Study 301: Has been diagnosed with a sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder during Study 301, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
- For Participants completed Study 301: Has been diagnosed with neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases during Study 301; or other systemic diseases that are inappropriate for the study;
- For Participants completed Study 301: Previously participated in any clinical trial other than HS-10506-301 within 3 months prior to screening;
- For new Participants: Has history of/current sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
- For new Participants: Has history of/current neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;
- For new Participants: Previously use of HS-10506;
- For new Participants: Previously participated in any clinical trial within 3 months prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Open-label, Phase 3 Study to Evaluate the Short-term and Long-term Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder
The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.
Read the detailed description
The study will comprise 4 periods : a Screening Period, a Run-in Period, an Open-Label Treatment Period during which participants will be treated for 4, 24, 36, or 48 consecutive weeks and a minimum 7-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 2-13 months.
- Conditions
- Insomnia Disorder
- Being tested
- HS-10506
- Keywords
- Clinical trial, insomnia disorder, open-label, long-term, phase 3
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10506Drug
HS-10506 tablet
| Study group | Role | What they receive |
|---|---|---|
| HS-10506 | Experimental | Participants will receive HS-10506 tablets, orally, once nightly for 4/24/36/48 consecutive weeks. Receives: Drug: HS-10506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AE)
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.
Measured: From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months
Incidence and severity of serious adverse events (SAE)
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.
Measured: From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months
Incidence and severity of adverse events of special interest (AESI)
An AESI (serious or non-serious) is any medical event specific to the investigational product or clinical trial.
Measured: 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 outcomes (11)
Number of Participants With Clinically Significant Change in hematology
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
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in clinical chemistry
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in urinalysis
Urinalysis will include glucose, ketones, urine red blood cells, urine white blood cells. Any clinically significant change in urinalysis values will be determined at the investigator's discretion.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
The PWC-20 is a 20-item questionnaire and the score of each item ranges from 0-3 (0=not present, 1=mild, 2=moderate, 3=severe) with higher scores indicating greater severity of withdrawal symptoms
Measured: The day after the last administration and at least 7 days after discontinuation of the medication
Rebound insomnia by subjective sleep onset latency (sSOL) during the follow-up period
Measured: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective wake after sleep onset (sWASO) during the follow-up period
Measured: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective total sleep time (sTST) during the follow-up period
Measured: Baseline, Follow-up Period (7-9 days)
Change from baseline in subjective sleep onset latency (sSOL) under the treatment of HS-10506
sSOL: estimated minutes from the time that the participant attempted to sleep until sleep onset as recorded in sleep diary
Measured: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective sleep efficiency (sSE) under the treatment of HS-10506
sSE: the ratio of subjective total sleep time (sTST) to subjective time in bed
Measured: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective wake after sleep onset (sWASO) under the treatment of HS-10506
sWASO: estimated minutes of wake at night from initial sleep onset to the time when the participant stopped trying to sleep as recorded in sleep diary
Measured: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective total sleep time (sTST) under the treatment of HS-10506
sTST: the total sleep time reported by the participant in sleep diary
Measured: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start12 Jun 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677384
- Sponsor's protocol ID
- HS-10506-303
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 3 Study to Evaluate the Short-term and Long-term Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07677384
- Acronym / sponsor ID
- HS-10506-303
- Conditions
- Insomnia Disorder
- Keywords
- Clinical trial, insomnia disorder, open-label, long-term, phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.
Detailed description
The study will comprise 4 periods : a Screening Period, a Run-in Period, an Open-Label Treatment Period during which participants will be treated for 4, 24, 36, or 48 consecutive weeks and a minimum 7-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 2-13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10506 | Experimental | Drug: HS-10506Participants will receive HS-10506 tablets, orally, once nightly for 4/24/36/48 consecutive weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);
- Participants are required to voluntarily sign the informed consent form;
- Body mass index (BMI): BMI (weight/height2 [kg/m2]) must be in the range of 18 to 35 kg/m2 (inclusive);
- For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;
- For new Participants: Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
Key exclusion criteria (18 listed)
- Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;
- Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;
- Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single/multi-target drugs within the past 2 weeks or 5 half-lives of the medication;
- Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;
- Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10506HS-10506 tablet | Drug | HS-10506 |
Primary outcome
Incidence and severity of adverse events (AE)
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
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.
Incidence and severity of serious adverse events (SAE)
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
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.
Incidence and severity of adverse events of special interest (AESI)
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
An AESI (serious or non-serious) is any medical event specific to the investigational product or clinical trial.
11 secondary outcomes
Number of Participants With Clinically Significant Change in hematology
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in clinical chemistry
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in urinalysis
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
Time frame: The day after the last administration and at least 7 days after discontinuation of the medication
Rebound insomnia by subjective sleep onset latency (sSOL) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective wake after sleep onset (sWASO) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective total sleep time (sTST) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Change from baseline in subjective sleep onset latency (sSOL) under the treatment of HS-10506
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective sleep efficiency (sSE) under the treatment of HS-10506
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective wake after sleep onset (sWASO) under the treatment of HS-10506
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Change from baseline in subjective total sleep time (sTST) under the treatment of HS-10506
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-10506 in people with Insomnia Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuping Wang, Principal Investigator (13501186298, wangyuping01@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.