Insomnia DisorderPhase 3NCT06975514
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
A Phase 3 study testing YZJ-1139 and Zolpidem in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 16 sites in China.
Trial summary
The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- YZJ-1139 and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 16 sitesChina
- Study dates
- 25 Mar 2025to 14 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged ≥ 18 to < 65 years.
- Meet the clinical diagnostic criteria for insomnia disorder as defined in ICSD-3 criteria.
- sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3 nights per week within 4 weeks prior to screening.
- Able to recognize 26 English letters and MMSE score indicats no cognitive impairment.
- During the run-in period and on Day 1 of the treatment period, sTSO ≥ 30 min for at least 3 nights in the last 7 sleep diaries and/or sWASO ≥ 60 min for at least 3 nights out of 7 nights as confirmed by the sleep diary prior to PSG monitoring.
- PSG results for 2 consecutive nights during the run-in period should meet the following conditions:
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- The mean LPS ≥ 30 min for 2 nights and ≥ 20 min for any one night; And/or the mean WASO ≥ 60 min for 2 nights, and ≥ 45 min either night.
- The mean SE ≤ 85% for 2nights, with the SE ≤ 87.5% for both nights .
- ISI score ≥ 15 at screening and on Day 1 of the treatment period .
- Have a bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m., and stay in bed for 6.5 to 9 hours for at least 5 nights in the last 7 sleep diaries as confirmed by the sleep diary prior to PSG monitoring during the run-in period and on Day 1 of the treatment period.
- Reproductive-age male and female participants must agree to use effective contraceptive measures from the screening visit through at least 30 days after the last dose of double-blind study treatment, and must not be planning to become pregnant or donate sperm/eggs during this period.
- Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form, have good compliance during participation in the study, and are willing to attend the visits.
Who cannot join
- Hypersensitivity to YZJ-1139 tablets or zolpidem or to their excipients.
- Have serious endocrine diseases, hematological diseases, cardiovascular and cerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases, autoimmune diseases, impaired respiratory function or other related diseases, or have other medical history that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
- Have insomnia disorder due to other causes such as chronic pain, headache, eczema, neurodermatitis, allergic rhinitis, and serious dermatitis (difficulty sleeping due to physical reasons, difficulty falling asleep due to medical reasons).
- Current or previous history of psychiatric or neurological disease such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
- Previous history of sleep-related respiratory disorders including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] therapy), periodic limb movement disorder, myasthenia gravis, restless legs syndrome, circadian rhythm sleep disturbances, narcolepsy or other sleep disorders: subjects with restless legs syndrome which is diagnosed by relevant diagnostic and treatment guidelines should be excluded. Those who have been cured of the above diseases can be enrolled.
- Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
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- Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder.
- Hyperthyroidism.
- History of alcohol abuse (defined as regular daily alcohol consumption exceeding the following criteria: approximately 720 mL of beer, or 240 mL of wine, or 60 mL of liquor) within the past 6 months.
- Regular daily consumption of excessive tea and coffee drinks (defined as consumption of > 4 cups of caffeinated beverages or > 400 mg of caffeine per day), or daily habituation to drinking caffeinated beverages beyond 18:00.
- Exclusion Criteria: Smokers who have smoked more than 10 cigarettes per day within 6 months prior to screening or smokers who are unable to refrain from falling asleep.
- Have any lifestyle that interferes with the study process or may interfere with sleep: for example, there will be travels across 3 or more time zones (mainland China is considered as 1 time zone) within the next 2 weeks or during the study period, or there will be shift work (night and daytime shift).
- History of drug abuse within the past 2 years, or positive urine drug screening for any indicator; history of drug taking or addiction, which is known through questioning.
- Have received any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, CYP3A inducers, CYP3A inhibitors, traditional Chinese medicines and traditional Chinese medicinal products with sleep-improving effects, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.
- Plan to undergo surgery during the study.
- Depression: Hamilton Depression Scale (HAMD) score ≥ 18; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14.
- Suicidal ideation with or without plan at screening or within 6 months prior to screening (score ≥ 3 on item 3 [suicide] of HAMD, or select "Yes" on item 3, 4 or 5 of suicidal ideation subscale of C-SSRS), or have any suicidal behavior in the past 10 years (as assessed by the suicidal ideation subscale of C-SSRS).
- ECG at screening shows QTcF interval prolongation (QTcF > 450 ms, QTcF=QT/(RR^0.33)).
- AST or ALT > 2 × the upper limit of normal (ULN), or Cr > 1.5 × ULN.
- Known to be human immunodeficiency virus (HIV) antibody positive at screening.
- Apnea-hypopnea index [AHI] or periodic limb movement index [PLMI] > 10 times/hour detected by PSG monitoring during the run-in period.
- Unable to avoid vaccination within 1 month prior to screening.
- Enrolled in another clinical trial and used any investigational drug within 1 month or 5 half-lives (whichever is longer) prior to the run-in period, or participation in another investigational trial at the same time during this trial.
- Previously participated in any clinical trial of YZJ-1139; or treated with other orexin receptor antagonists of appropriate amount and sufficient duration and who, in the opinion of the investigator, have failed treatment due to efficacy or safety.
- Pregnant or lactating women.
- Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Peking University People's Hospital
Beijing
ChengDu Second People's Hospital
Chengdu
ChongQing Traditional Chinese Medicine Hospital
Chongqing
Deyang People's Hospital
Deyang
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan
The Second Affiliated Hospital Of NanChang University
Nanchang
The First Affiliated Hospital of Ningbo University
Ningbo
ShengJing Hospital Of China Medical University
Shenyang
The Third Hospital of Hebei Medical University
Shijiazhuang
SuZhou GuangJi Hospital
Suzhou
The Second Affiliated Hospital of Soochow University
Suzhou
Tianjin Anding Hospital
Tianjin
Wuhan No.1 Hospital
Wuhan
Yan'an University Xianyang Hospital
Yan’an
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Randomized, Double-blind, Active-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder
The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Conditions
- Insomnia Disorder
- Being tested
- YZJ-1139, Zolpidem
- 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.
YZJ-1139Drug
YZJ-1139 20mg tablets, once daily in the evening
ZolpidemDrug
Zolpidem 10mg tablets, once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| YZJ-1139 group | Experimental | Not described Receives: Drug: YZJ-1139 |
| Zolpidem group | Active comparator | Not described Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Mean Objective Wake After Sleep Onset (WASO)
WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by polysomnography (PSG).
Measured: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline of Mean Objective Sleep Efficiency (SE)
SE is 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, Day 1/Day 2, Day 27/Day 28
Change from baseline of Mean Objective Total Sleep Time (TST)
TST is defined as total sleep time measured by PSG.
Measured: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline of Mean Objective Latency to Persistent Sleep (LPS)
LPS is defined as latency to persistent sleep measured by PSG.
Measured: Baseline, Day 1/Day 2, Day 27/Day 28
Secondary outcomes (10)
Change from baseline of Mean Subject Wake After Sleep Onset (sWASO)
sWASO is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Week1, Week 4
Change from baseline of Mean Subject Sleep Efficiency (sSE)
sSE is defined as percentage of time spent in bed asleep, calculated as subject total sleep time (sTST) divided by interval from lights off until lights on, multiplied by 100.
Measured: Baseline, Week1, Week 4
Change from baseline of Mean subject Total Sleep Time (sTST)
sTST is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Week1, Week 4
Change from baseline of Mean Subjective Time to Sleep Onset (sTSO)
sTSO is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Week1, Week 4
Change from baseline of Mean Subjective Number of awakenings (sNAW)
sNAW is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Week1, Week 4
Change from baseline of Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM])
Wakefulness, N1, N2, N3, REM, NREM are measured by PSG in minutes, and expressed as the percent change from time spent in bed (TIB) and TST.
Measured: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline of Sleep structure (REM latency, number of awakenings [NAW], arousal index for REM and NREM)
REM latency, NAW and the arousal index for REM and NREM are measured by PSG.
Measured: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline in the mean subjective sleep quality score
Subjective sleep quality score is a self-report assessment of participant perception of the effects of a medication on their sleep. Higher score indicated severe insomnia problem.
Measured: Baseline, Week1, Week 4
Change from baseline in the ISI score
Insomnia Severity Index is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Higher score indicated severe insomnia problem.
Measured: Baseline, Day15 and Day 28
Percentage of participants on each scale of Global Impression of Insomnia (PGI-I) each item
the PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak).
Measured: Day15 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start25 Mar 2025
- Primary completion21 Jul 2025
- Study completion14 Aug 2025
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.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975514
- Sponsor's protocol ID
- YZJ-1139-3-02
- Status last verified
- Jun 2026
- First submitted
- 9 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder
- ClinicalTrials.gov ID
- NCT06975514
- Acronym / sponsor ID
- YZJ-1139-3-02
- Conditions
- Insomnia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 16 May 2025 (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 main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YZJ-1139 group | Experimental | Drug: YZJ-1139 |
| Zolpidem group | Active comparator | Drug: Zolpidem |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females, aged ≥ 18 to < 65 years.
- Meet the clinical diagnostic criteria for insomnia disorder as defined in ICSD-3 criteria.
- sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3 nights per week within 4 weeks prior to screening.
- Able to recognize 26 English letters and MMSE score indicats no cognitive impairment.
- During the run-in period and on Day 1 of the treatment period, sTSO ≥ 30 min for at least 3 nights in the last 7 sleep diaries and/or sWASO ≥ 60 min for at least 3 nights out of 7 nights as confirmed by the sleep diary prior to PSG monitoring.
Key exclusion criteria (26 listed)
- Hypersensitivity to YZJ-1139 tablets or zolpidem or to their excipients.
- Have serious endocrine diseases, hematological diseases, cardiovascular and cerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases, autoimmune diseases, impaired respiratory function or other related diseases, or have other medical history that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
- Have insomnia disorder due to other causes such as chronic pain, headache, eczema, neurodermatitis, allergic rhinitis, and serious dermatitis (difficulty sleeping due to physical reasons, difficulty falling asleep due to medical reasons).
- Current or previous history of psychiatric or neurological disease such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
- Previous history of sleep-related respiratory disorders including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] therapy), periodic limb movement disorder, myasthenia gravis, restless legs syndrome, circadian rhythm sleep disturbances, narcolepsy or other sleep disorders: subjects with restless legs syndrome which is diagnosed by relevant diagnostic and treatment guidelines should be excluded. Those who have been cured of the above diseases can be enrolled.
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 |
|---|---|---|
| YZJ-1139YZJ-1139 20mg tablets, once daily in the evening | Drug | YZJ-1139 group |
| ZolpidemZolpidem 10mg tablets, once daily in the evening | Drug | Zolpidem group |
Primary outcome
Change from baseline of Mean Objective Wake After Sleep Onset (WASO)
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by polysomnography (PSG).
Change from baseline of Mean Objective Sleep Efficiency (SE)
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
SE is 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.
Change from baseline of Mean Objective Total Sleep Time (TST)
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
TST is defined as total sleep time measured by PSG.
Change from baseline of Mean Objective Latency to Persistent Sleep (LPS)
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
LPS is defined as latency to persistent sleep measured by PSG.
10 secondary outcomes
Change from baseline of Mean Subject Wake After Sleep Onset (sWASO)
Time frame: Baseline, Week1, Week 4
Change from baseline of Mean Subject Sleep Efficiency (sSE)
Time frame: Baseline, Week1, Week 4
Change from baseline of Mean subject Total Sleep Time (sTST)
Time frame: Baseline, Week1, Week 4
Change from baseline of Mean Subjective Time to Sleep Onset (sTSO)
Time frame: Baseline, Week1, Week 4
Change from baseline of Mean Subjective Number of awakenings (sNAW)
Time frame: Baseline, Week1, Week 4
Change from baseline of Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM])
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline of Sleep structure (REM latency, number of awakenings [NAW], arousal index for REM and NREM)
Time frame: Baseline, Day 1/Day 2, Day 27/Day 28
Change from baseline in the mean subjective sleep quality score
Time frame: Baseline, Week1, Week 4
Change from baseline in the ISI score
Time frame: Baseline, Day15 and Day 28
Percentage of participants on each scale of Global Impression of Insomnia (PGI-I) each item
Time frame: Day15 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YZJ-1139 and Zolpidem in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 16 sites in China.
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 12 inclusion and 26 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Mean Objective Wake After Sleep Onset (WASO) (time frame: Baseline, Day 1/Day 2, Day 27/Day 28). The study lists 4 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 29 Jun 2026.