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

NCT07587385 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-10506-301
• Study Type: interventional
• Target: 732
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insomnia Disorder

Keywords

Clinical trial; insomnia disorder; phase 3

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change from baseline of subjective sleep onset latency (sSOL) under the treatment of HS-10506

  Baseline, Week 4, Week 12

• Change from baseline in subjective sleep efficiency (sSE) under the treatment of HS-10506

  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

  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

  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

  Week 4, Week 12

Study Arms (2)

HS-10506

EXPERIMENTAL

Participants will receive HS-10506 tablets, orally, once nightly for 84 consecutive nights

Drug: HS-10506

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched in appearance to HS-10506 tablets, orally, once nightly for 84 consecutive nights

Drug: Placebo

Interventions

HS-10506 DRUG

HS-10506 tablet

HS-10506

Placebo DRUG

Placebo tablet matched to HS-10506

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Huan Yu Yu Principal Investigator

CONTACT

021-54602182; dr.yuhuan@163.com

Yuping Wang Wang Principal Investigator

CONTACT

13501186298; wangyuping01@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): August 12, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04