A Study of HS-10506 in Chinese Patients With Insomnia Disorder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: HS-10506; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 732
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Huan Yu Yu Principal Investigator; Phone Number: 021-54602182; Email: dr.yuhuan@163.com
• Study Contact Backup: Name: Yuping Wang Wang Principal Investigator; Phone Number: 13501186298; Email: wangyuping01@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);
2. participants are required to voluntarily sign the informed consent form;
3. Body mass index (BMI): BMI (weight/height2 [kg/m2]) must be in the range of 18 to 35 kg/m2 (inclusive);
4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
5. Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;
6. 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;
7. 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.

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;
5. 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;
6. 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;
7. 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;
8. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;
9. Has taken more than 3 naps per week for > 1 hour each time within the past 2 weeks prior to screening;
10. 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;
11. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;
12. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;
13. Has a history of smoking ≥ 10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;
14. Has a history of caffeine consumption ≥ 600 mg per day or can't obey the rules of caffeine restriction;
15. Previously participated in any clinical trial of HS-10506;
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10506; Participants will receive HS-10506 tablets, orally, once nightly for 84 consecutive nights	Drug: HS-10506; HS-10506 tablet
Placebo Comparator: Placebo; Participants will receive placebo matched in appearance to HS-10506 tablets, orally, once nightly for 84 consecutive nights	Drug: Placebo; Placebo tablet matched to HS-10506

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Baseline, Night 27 and Night 28, Night 83 and Night 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	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	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.	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	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	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)	Baseline, Follow-up Period (3-6 days)

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): August 12, 2028

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Clinical trial; phase 3; insomnia disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HS-10506-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No