Insomnia DisorderPhase 3NCT07587385
A Study 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 phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) 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?
- Yes, some participants may receive a placebo
- How many people
- 732 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2026to 12 Aug 2028
- 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);
- Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
- Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;
- Subjective sleep assessment: 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 V2 visit and V3 visit respectively;
- PSG: Participants must demonstrate a 2-night mean LPS ≥ 30 minutes with neither night < 20 minutes, a 2-night mean WASO ≥ 30 minutes with neither nigh < 20 minutes, and a 2-night mean TST < 7 hours.
Who cannot join
- 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;
- Has a Apnea-Hypopnea Index (AHI) ≥ 10 times/hour or periodic leg movement with arousal index (PLMAI) ≥ 10 times/hour monitored by PSG at V2 visit;
- 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;
- Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;
- 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;
Show all 16Show fewer
- 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 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 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 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;
- 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;
- Previously participated in any clinical trial of HS-10506;
- Has any circumstances or conditions, which, in the opinion of the investigator, may affect the participant's full participation in the study or compliance with the protocol.
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 Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder
The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
Read the detailed description
The study will comprise 4 periods : a Screening Period, a Run-in Period, a Treatment Period during which participants will be treated for 84 nights (3 month) and a minimum 3-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 105-113 days.
- Conditions
- Insomnia Disorder
- Being tested
- HS-10506, Placebo
- Keywords
- Clinical trial, insomnia disorder, 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
PlaceboDrug
Placebo tablet matched to HS-10506
| Study group | Role | What they receive |
|---|---|---|
| HS-10506 | Experimental | Participants will receive HS-10506 tablets, orally, once nightly for 84 consecutive nights Receives: Drug: HS-10506 |
| Placebo | Placebo comparator | Participants will receive placebo matched in appearance to HS-10506 tablets, orally, once nightly for 84 consecutive nights Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG)
Measured: Baseline, Night 27 and Night 28,Night 83 and Night 84
Change from baseline of mean wakefulness after sleep onset (WASO) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG
Measured: Baseline, Night 27 and Night 28, Night 83 and Night 84
Secondary outcomes (10)
Change from baseline of 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, Week 4, Week 12
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, sTST: the total sleep time reported by the participant in sleep diary.
Measured: Baseline, Week 4, Week 12
Change from baseline in total sleep time (TST) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
TST was defined as the total sleep time in minutes, the total sleep time is the total amount of stages 1, 2, 3 non rapid eye-movement (NREM) and rapid-eye-movement (REM) sleep time, as measured by PSG
Measured: Baseline, Night 27 and Night 28, Night 83 and Night 84
Change from baseline in sleep efficiency (SE) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
SE was defined as percentage (%) of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG multiplied by 100
Measured: Baseline, Night 27 and Night 28, Night 83 and Night 84
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: Week 4, Week 12
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, Week 4, Week 12
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 4 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 4 months
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
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 3 days after discontinuation of the medication
Rebound insomnia by sleep diary during the follow-up period
Rebound insomnia is defined as worsened sleep relative to baseline after study drug treatment was completed, rebound insomnia is assessed using the data collected in sleep diary, including estimated minutes from the time that the participant attempted to sleep until sleep onset as recorded in sleep diary (subjective sleep onset latency, sSOL), 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 (subjective wake after sleep onset, sWASO) and the total sleep time reported by the participant in sleep diary ( subjective total sleep time, sTST)
Measured: Baseline, Follow-up Period (3-6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start29 May 2026 (estimated)
- Primary completion28 Jun 2028 (estimated)
- Study completion12 Aug 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 732 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
- NCT07587385
- Sponsor's protocol ID
- HS-10506-301
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 14 May 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07587385
- Acronym / sponsor ID
- HS-10506-301
- Conditions
- Insomnia Disorder
- Keywords
- Clinical trial, insomnia disorder, phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- 28 Jun 2028 (estimated)
- Study completion
- 12 Aug 2028 (estimated)
- First posted
- 14 May 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 phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
Detailed description
The study will comprise 4 periods : a Screening Period, a Run-in Period, a Treatment Period during which participants will be treated for 84 nights (3 month) and a minimum 3-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 105-113 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10506 | Experimental | Drug: HS-10506Participants will receive HS-10506 tablets, orally, once nightly for 84 consecutive nights |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched in appearance to HS-10506 tablets, orally, once nightly for 84 consecutive nights |
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);
- Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
- Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;
Key exclusion criteria (16 listed)
- 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;
- Has a Apnea-Hypopnea Index (AHI) ≥ 10 times/hour or periodic leg movement with arousal index (PLMAI) ≥ 10 times/hour monitored by PSG at V2 visit;
- 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;
- Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;
- 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;
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 |
| PlaceboPlacebo tablet matched to HS-10506 | Drug | Placebo |
Primary outcome
Change from baseline of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
Time frame: Baseline, Night 27 and Night 28,Night 83 and Night 84
LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG)
Change from baseline of mean wakefulness after sleep onset (WASO) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
Time frame: Baseline, Night 27 and Night 28, Night 83 and Night 84
WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG
10 secondary outcomes
Change from baseline of subjective sleep onset latency (sSOL) under the treatment of HS-10506
Time frame: Baseline, Week 4, Week 12
Change from baseline in subjective sleep efficiency (sSE) under the treatment of HS-10506
Time frame: Baseline, Week 4, Week 12
Change from baseline in total sleep time (TST) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
Time frame: Baseline, Night 27 and Night 28, Night 83 and Night 84
Change from baseline in sleep efficiency (SE) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506
Time frame: Baseline, Night 27 and Night 28, Night 83 and Night 84
Change from baseline in subjective wake after sleep onset (sWASO) under the treatment of HS-10506
Time frame: Week 4, Week 12
Change from baseline in subjective total sleep time (sTST) under the treatment of HS-10506
Time frame: Baseline, Week 4, Week 12
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 4 months
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 4 months
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
Time frame: The day after the last administration and at least 3 days after discontinuation of the medication
Rebound insomnia by sleep diary during the follow-up period
Time frame: Baseline, Follow-up Period (3-6 days)
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 14 May 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 16 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 14 May 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. Some participants in this study may receive a placebo. 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 Huan Yu Yu Principal Investigator (021-54602182, dr.yuhuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 (time frame: Baseline, Night 27 and Night 28,Night 83 and Night 84). The study lists 2 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 14 May 2026.