Insomnia DisorderPhase 3NCT05525637
Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder
A Phase 3 study testing YZJ-1139 20mg and YZJ-1139 40mg in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 83 sites in China.
Trial summary
The main purpose of this study is to assess efficacy and safety of YZJ-1139 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 20mg and YZJ-1139 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,037 participants
- Where
- 83 sitesChina
- Study dates
- 17 Dec 2021to 27 Sep 2023
- 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
- Subjects who meet all of the following criteria may be enrolled in the study:
- Aged ≥ 18 to < 65 years.
- Meet the clinical diagnostic criteria for insomnia disorder as defined in International Classification of Sleep Disorders, 3rd Edition (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 28 days (4 weeks) prior to screening.
- During the run-in period or 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 Polysomnography (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 of 2 nights is ≥ 30 min, with the LPS ≥ 20 min for any night;
- And/or the mean WASO of 2 nights is ≥ 60 min, with neither night < 45 min;
- The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights.
- ISI score ≥ 15 at screening and on Day 1 of the treatment period.
- Agree to follow the habitual bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m. every day, and stay in bed for 6.5 to 9 hours per night during the study.
- 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 days in the last 7 sleep diaries as confirmed by the sleep diary prior to PSG monitoring during the run-in period or on Day 1 of the treatment period.
- Female subjects are confirmed to be non-pregnant at screening; both men of reproductive potential and women of childbearing potential should agree to use medically acceptable and effective contraception throughout the study and within 3 months after the end of the study.
- Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form (ICF), have good compliance during participation in the study, and are willing to attend the visits.
Who cannot join
- Subjects who meet any of the following criteria should be excluded from this 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 Columbia-Suicide Severity Rating Scale (C-SSRS)), or have any suicidal behavior in the past 10 years (as assessed by the suicidal ideation subscale of C-SSRS).
- Apnea-hypopnea index (AHI) and/or periodic limb movement index (PLMI) > 10 times/hour detected by PSG monitoring during the run-in period.
- Repeat electrocardiogram (ECG) at screening shows QTcF interval prolongation (QTcF > 450 ms) (the ECG should be repeated 2 more times only if the initial ECG shows QTcF interval > 450 ms).
- 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.
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- 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).
- Previous history of nervous system disorders 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, 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.
- Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
- Plan to undergo surgery during the study.
- Have received any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, cytochrome P450 3A (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.
- History of drug taking or addiction, which is known through questioning.
- 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).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 × the upper limit of normal (ULN), or Creatinine (Cr) > 1.5 × ULN.
- 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 2 years.
- History of drug abuse within the past 2 years, or positive urine drug screening for any indicator.
- 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.
- Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder.
- Have positive infectious disease screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and human immunodeficiency virus (HIV) antibody at screening.
- Unable to avoid vaccination within 1 month prior to screening or during the first treatment phase.
- Have participated in clinical studies of other drugs within the past 1 month or 5 half-lives (whichever is longer), or plan to participate in other studies simultaneously during participation in this study.
- Pregnant or lactating women.
- History of allergy to the investigational product or its components.
- Have prior participation in clinical studies of YZJ-1139 Tablets.
- Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
China83 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Beijing Hui Long Guan Hospital, Capital Medical University
Beijing
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Tsinghua Changgung Hospital
Beijing
China-Japan Friendship Hospital
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
Xuanwu Hospital Capital Medical University
Beijing
The First affiliated hospital of bengbu medical college
Bengbu
Binzhou Medical University Hospital
Binzhou
The First Bethune Hospital Of Jilin University
Changchun
The First Hospital of ChangSha
Changsha
The Second XiangYa Hospital Of Central University
Changsha
The Secong People's Hospital Of HuNan Province
Changsha
Xiangya Hospital Central South University
Changsha
The Fourth People's Hospital Of ChengDu
Chengdu
Army Medical Center of PLA
Chongqing
ChongQing Eleventh People's Hospital
Chongqing
ChongQing Mental Health Center
Chongqing
ChongQing Traditional Chinese Medical Hospital
Chongqing
ChongQing University Three Gorges Hospital
Chongqing
People's Hospital Of DeYang City
Deyang
The First Affiliated Hospital Of FuJan Medical University
Fuzhou
Guangdong Provincial People's Hospital
Guangzhou
Nanfang Hospital Southern Medical University
Guangzhou
The First Affiliated Hospital of Jinan University
Guangzhou
The Affiliated Hospital Of GuiZhou Medical University
Guiyang
The 2nd Affiliated Hospital Of Harbin Medical University
Ha’erbin
HanDan Central Hospital
Handan
Affiliated HangZhou First People's Hospital
Hangzhou
Sir Run Run Shaw hospital
Hangzhou
Chaohu hospital of anhui medical university
Hefei
The Second Hospital Of AnHui Medical University
Hefei
The Secong People's Hospital Of HeFei
Hefei
Affiliated NanHua Hospital,University Of South China
Hengyang
JiangMen Central Hospital
Jiangmen
ShanDong Provincial QianFoShan Hospital
Jinan
Jingjiang People's Hospital
Jingjiang
Shandong Daizhuang Hospital
Jining
Jiujiang University Affiliated Hospital
Jiujiang
First People's Hospital of Yunnan Province
Kunming
LiaoCheng People's Hospital
Liaocheng
HeNan University Of Science &Technology
Luoyang
The Affiliated Hospital Of Southwest Medical University
Luzhou
JiangXi Provincial People's Hospital
Nanchang
The First Affiliated Hospital Of NanChang University
Nanchang
The Second Affiliated Hospital Of NanChang University
Nanchang
Zhongda Hospital Southeast Unveristy
Nanjing
NanTong First People's Hospital
Nantong
NingBo KangNing Hospital
Ningbo
NingBo Medical Center LiHuiLi Hospital
Ningbo
QingDao Center Medical Group
Qingdao
QingDao Municipal Hospital
Qingdao
The affilated hospital of qingdao university
Qingdao
The 2nd Affiliated Hospital Of FuJan Medical University
Quanzhou
Affiliated ZhongShan Hospital,University Of FuDan
Shanghai
HuaShan Hospital Fudan University
Shanghai
ShengJing Hospital Of China Medical University
Shenyang
ShenZhen People's Hospital
Shenzhen
The First Hospital of Hebei Medical University
Shijiazhuang
The Third Hospital of Hebei Medical University
Shijiazhuang
Jilin Neuropsychiatric Hospital
Siping
SuZhou GuangJi Hospital
Suzhou
The First People's Hospital Of KunShan
Suzhou
The Second Affiliated Hospital of Soochow University
Suzhou
First Hospital Of ShanXi Medical University
Taiyuan
Peking University BinHai Hospital
Tianjin
Tianjin Huanhu Hospital
Tianjin
Tianjin Mental Health Center
Tianjin
The Center Hospital of WuHan
Wuhan
Wuhan Mental Health Centre
Wuhan
Affiliated Hospital Of Jiangnan University
Wuxi
WuXi People's Hospital
Wuxi
Air Force Medical University
Xi'an
XianYang Hospital OF Yan'an University
Xianyang
HeNan Mental Hospital
Xinxiang
The Affiliated Hospital Of XuZhou Medical University
Xuzhou
XuZhou Central Hospital
Xuzhou
The First Affiliated Hospital Of ZhenZhou University
Zhengzhou
ZhenZhou Central Hospital
Zhengzhou
ZhenJiang Mental Health Center
Zhenjiang
ZhuMaDian Second People's Hospital
Zhumadian
ZiGong First People's Hospital
Zigong
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 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 and safety of YZJ-1139 in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Conditions
- Insomnia Disorder
- Being tested
- YZJ-1139 20mg, YZJ-1139 40mg, Placebo
- 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-1139 20mgDrug
YZJ-1139 20mg tablets, once daily in the evening
YZJ-1139 40mgDrug
YZJ-1139 40mg tablets, once daily in the evening
PlaceboDrug
Match placebo tablets, once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| YZJ-1139 20mg | Experimental | Not described Receives: Drug: YZJ-1139 20mg |
| YZJ-1139 40mg | Experimental | Not described Receives: Drug: YZJ-1139 40mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the subjective sleep efficiency (sSE) after 14 days of treatment
Subjective Sleep efficiency variation assessed by the sleep diary questionnaire at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the subjective Sleep efficiency. A negative change from baseline indicates a decrease in subjective Sleep efficiency
Measured: from baseline to week 2
Change from baseline in the sleep efficiency (SE) after 14 days of treatment
Sleep efficiency variation assessed by polysomnography at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Measured: from baseline to day 14
Secondary outcomes (20)
Change from baseline in the subjective sleep efficiency (sSE) after 7 days of treatment
sSE is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, week 1
Changes from baseline in the Subjective time to sleep onset (sTSO) after 14 days of treatment for subjects entering the second treatment phase
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, week 1, week 2
Changes from baseline in the Subjective wake after sleep onset (sWASO) after 14 days of treatment for subjects entering the second treatment phase
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, week 1, week 2
Changes from baseline in the Subjective total sleep time (sTST) after 14 days of treatment for subjects entering the second treatment phase
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, week 1, week 2
Changes from baseline in the Subjective number of awakenings (sNAW) after 14 days of treatment for subjects entering the second treatment phase
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, week 1, week 2
Changes from baseline in the SE after 2 days of treatment
SE assessed by polysomnography at 2 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Measured: Baseline, Day1/Day2
Latency to persistent sleep (LPS) after 2 and 14 days of treatment
LPS assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Measured: Baseline, Day1/Day2, Day13/Day14
Wake after sleep onset (WASO) after 2 and 14 days of treatment
WASO assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Measured: Baseline, Day1/Day2, Day13/Day14
Total sleep time (TST) after 2 and 14 days of treatment
TST assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Measured: Baseline, Day1/Day2, Day13/Day14
Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM], REM latency, number of awakenings [NAW], arousal index for REM and NREM) after 2 and 14 days of treatment
Sleep structure assessed by polysomnography at 2 and 14 days of treatment from baseline.
Measured: Baseline, Day1/Day2, Day13/Day14
Change from baseline in the mean subjective sleep quality score after 7 and 14 days of treatment for subjects
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, Week 1, Week 2
Percentage of Participants on each scale of Global Impression of Insomnia (PGI-I) each Item at 14 days of treatment
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: Day 14
Changes from baseline in the sSE after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
sSE are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTSO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sWASO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTST after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sNAW after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Measured: Baseline, Day 30, Day 90, and Day 180
Change from baseline in the mean subjective sleep quality score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
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, Day 30, Day 90, and Day 180
Change from baseline in the Insomnia Severity Index (ISI) score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
ISI is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Higher score indicated severe insomnia problem.
Measured: Baseline, Day 30, Day 90, and Day 180
Percentage of Participants who enter the second treatment phase on each scale of Patient Global Impressions - ImprovementGlobal Impression of Insomnia (PGI-I) each Item at 30, 90 and 180 days of treatment
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: Day 30, Day 90, and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start17 Dec 2021
- Primary completion7 Jul 2023
- Study completion27 Sep 2023
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
- 1,037 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
- NCT05525637
- Sponsor's protocol ID
- YZJ-1139-3-01
- Status last verified
- Jun 2026
- First submitted
- 24 Aug 2022
- Last updated
- 30 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder
- ClinicalTrials.gov ID
- NCT05525637
- Acronym / sponsor ID
- YZJ-1139-3-01
- Conditions
- Insomnia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 1 Sep 2022 (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 and safety of YZJ-1139 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
- 3
| Arm | Type | Receives |
|---|---|---|
| YZJ-1139 20mg | Experimental | Drug: YZJ-1139 20mg |
| YZJ-1139 40mg | Experimental | Drug: YZJ-1139 40mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects who meet all of the following criteria may be enrolled in the study:
- Aged ≥ 18 to < 65 years.
- Meet the clinical diagnostic criteria for insomnia disorder as defined in International Classification of Sleep Disorders, 3rd Edition (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 28 days (4 weeks) prior to screening.
- During the run-in period or 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 Polysomnography (PSG) monitoring.
Key exclusion criteria (27 listed)
- Subjects who meet any of the following criteria should be excluded from this study:
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-1139 20mgYZJ-1139 20mg tablets, once daily in the evening | Drug | YZJ-1139 20mg |
| YZJ-1139 40mgYZJ-1139 40mg tablets, once daily in the evening | Drug | YZJ-1139 40mg |
| PlaceboMatch placebo tablets, once daily in the evening | Drug | Placebo |
Primary outcome
Change from baseline in the subjective sleep efficiency (sSE) after 14 days of treatment
Time frame: from baseline to week 2
Subjective Sleep efficiency variation assessed by the sleep diary questionnaire at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the subjective Sleep efficiency. A negative change from baseline indicates a decrease in subjective Sleep efficiency
Change from baseline in the sleep efficiency (SE) after 14 days of treatment
Time frame: from baseline to day 14
Sleep efficiency variation assessed by polysomnography at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
20 secondary outcomes
Change from baseline in the subjective sleep efficiency (sSE) after 7 days of treatment
Time frame: Baseline, week 1
Changes from baseline in the Subjective time to sleep onset (sTSO) after 14 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, week 1, week 2
Changes from baseline in the Subjective wake after sleep onset (sWASO) after 14 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, week 1, week 2
Changes from baseline in the Subjective total sleep time (sTST) after 14 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, week 1, week 2
Changes from baseline in the Subjective number of awakenings (sNAW) after 14 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, week 1, week 2
Changes from baseline in the SE after 2 days of treatment
Time frame: Baseline, Day1/Day2
Latency to persistent sleep (LPS) after 2 and 14 days of treatment
Time frame: Baseline, Day1/Day2, Day13/Day14
Wake after sleep onset (WASO) after 2 and 14 days of treatment
Time frame: Baseline, Day1/Day2, Day13/Day14
Total sleep time (TST) after 2 and 14 days of treatment
Time frame: Baseline, Day1/Day2, Day13/Day14
Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM], REM latency, number of awakenings [NAW], arousal index for REM and NREM) after 2 and 14 days of treatment
Time frame: Baseline, Day1/Day2, Day13/Day14
Change from baseline in the mean subjective sleep quality score after 7 and 14 days of treatment for subjects
Time frame: Baseline, Week 1, Week 2
Percentage of Participants on each scale of Global Impression of Insomnia (PGI-I) each Item at 14 days of treatment
Time frame: Day 14
Changes from baseline in the sSE after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTSO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sWASO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTST after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sNAW after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Change from baseline in the mean subjective sleep quality score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Change from baseline in the Insomnia Severity Index (ISI) score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time frame: Baseline, Day 30, Day 90, and Day 180
Percentage of Participants who enter the second treatment phase on each scale of Patient Global Impressions - ImprovementGlobal Impression of Insomnia (PGI-I) each Item at 30, 90 and 180 days of treatment
Time frame: Day 30, Day 90, and Day 180
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 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
83 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 20mg and YZJ-1139 40mg in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 83 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 14 inclusion and 27 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 30 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 83 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. 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?
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 in the subjective sleep efficiency (sSE) after 14 days of treatment (time frame: from baseline to week 2). 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 30 Jun 2026.