New sleep aid YZJ-1139 put to the test in large trial

NCT ID NCT05525637

Symptom relief Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This phase 3 study tests whether YZJ-1139 tablets help adults with insomnia fall asleep faster and sleep more efficiently. Participants receive either 20 mg, 40 mg, or a placebo daily for two weeks. Sleep is measured using both sleep diaries and overnight lab tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: YZJ-1139
What this could lead to: If successful, this could provide a new medication option for people with insomnia, improving sleep quality and reducing time to fall asleep.
What could go wrong: This is a phase 3 trial, but results may not show significant benefit over placebo. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,037 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Subjects who meet all of the following criteria may be enrolled in the study: 1. Aged ≥ 18 to \< 65 years. 2. Meet the clinical diagnostic criteria for insomnia disorder as defined in International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. 3. 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. 4. 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. 5. PSG results for 2 consecutive nights during the run-in period should meet the following conditions: * 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. 6. ISI score ≥ 15 at screening and on Day 1 of the treatment period. 7. 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. 8. 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. 9. 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. 10. 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. Exclusion Criteria: * Subjects who meet any of the following criteria should be excluded from this study: 1. Depression: Hamilton Depression Scale (HAMD) score ≥ 18; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14. 2. 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). 3. Apnea-hypopnea index (AHI) and/or periodic limb movement index (PLMI) \> 10 times/hour detected by PSG monitoring during the run-in period. 4. 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). 5. 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. 6. 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). 7. 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. 8. 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. 9. Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls. 10. Plan to undergo surgery during the study. 11. 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. 12. History of drug taking or addiction, which is known through questioning. 13. 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). 14. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 × the upper limit of normal (ULN), or Creatinine (Cr) \> 1.5 × ULN. 15. Hyperthyroidism. 16. 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. 17. History of drug abuse within the past 2 years, or positive urine drug screening for any indicator. 18. 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. 19. Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder. 20. Have positive infectious disease screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and human immunodeficiency virus (HIV) antibody at screening. 21. Unable to avoid vaccination within 1 month prior to screening or during the first treatment phase. 22. 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. 23. Pregnant or lactating women. 24. History of allergy to the investigational product or its components. 25. Have prior participation in clinical studies of YZJ-1139 Tablets. 26. Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia disorder

Contacts and locations

Locations

Affiliated HangZhou First People's Hospital

Hangzhou, China
Affiliated Hospital Of Jiangnan University

Wuxi, China
Affiliated NanHua Hospital,University Of South China

Hengyang, China
Affiliated ZhongShan Hospital,University Of FuDan

Shanghai, China
Air Force Medical University

Xi'an, China
Army Medical Center of PLA

Chongqing, China
Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China
Beijing Hui Long Guan Hospital, Capital Medical University

Beijing, China
Beijing Tiantan Hospital, Capital Medical University

Beijing, China
Beijing Tsinghua Changgung Hospital

Beijing, China
Binzhou Medical University Hospital

Binzhou, China
Chaohu hospital of anhui medical university

Hefei, China
China-Japan Friendship Hospital

Beijing, China
ChongQing Eleventh People's Hospital

Chongqing, China
ChongQing Mental Health Center

Chongqing, China
ChongQing Traditional Chinese Medical Hospital

Chongqing, China
ChongQing University Three Gorges Hospital

Chongqing, China
First Hospital Of ShanXi Medical University

Taiyuan, China
First People's Hospital of Yunnan Province

Kunming, China
Guangdong Provincial People's Hospital

Guangzhou, China
HanDan Central Hospital

Handan, China
HeNan Mental Hospital

Xinxiang, China
HeNan University Of Science &Technology

Luoyang, China
HuaShan Hospital Fudan University

Shanghai, China
JiangMen Central Hospital

Jiangmen, China
JiangXi Provincial People's Hospital

Nanchang, China
Jilin Neuropsychiatric Hospital

Siping, China
Jingjiang People's Hospital

Jingjiang, China
Jiujiang University Affiliated Hospital

Jiujiang, China
LiaoCheng People's Hospital

Liaocheng, China
NanTong First People's Hospital

Nantong, China
Nanfang Hospital Southern Medical University

Guangzhou, China
NingBo KangNing Hospital

Ningbo, China
NingBo Medical Center LiHuiLi Hospital

Ningbo, China
Peking University BinHai Hospital

Tianjin, China
Peking University First Hospital

Beijing, China
Peking University People's Hospital

Beijing, China
People's Hospital Of DeYang City

Deyang, China
QingDao Center Medical Group

Qingdao, China
QingDao Municipal Hospital

Qingdao, China
ShanDong Provincial QianFoShan Hospital

Jinan, China
Shandong Daizhuang Hospital

Jining, China
ShenZhen People's Hospital

Shenzhen, China
ShengJing Hospital Of China Medical University

Shenyang, China
Sir Run Run Shaw hospital

Hangzhou, China
SuZhou GuangJi Hospital

Suzhou, China
The 2nd Affiliated Hospital Of FuJan Medical University

Quanzhou, China
The 2nd Affiliated Hospital Of Harbin Medical University

Ha’erbin, China
The Affiliated Hospital Of GuiZhou Medical University

Guiyang, China
The Affiliated Hospital Of Southwest Medical University

Luzhou, China
The Affiliated Hospital Of XuZhou Medical University

Xuzhou, China
The Center Hospital of WuHan

Wuhan, China
The First Affiliated Hospital Of FuJan Medical University

Fuzhou, China
The First Affiliated Hospital Of NanChang University

Nanchang, China
The First Affiliated Hospital Of ZhenZhou University

Zhengzhou, China
The First Affiliated Hospital of Jinan University

Guangzhou, China
The First Bethune Hospital Of Jilin University

Changchun, China
The First Hospital of ChangSha

Changsha, China
The First Hospital of Hebei Medical University

Shijiazhuang, China
The First People's Hospital Of KunShan

Suzhou, China
The First affiliated hospital of bengbu medical college

Bengbu, China
The Fourth People's Hospital Of ChengDu

Chengdu, China
The Second Affiliated Hospital Of NanChang University

Nanchang, China
The Second Affiliated Hospital of Soochow University

Suzhou, China
The Second Hospital Of AnHui Medical University

Hefei, China
The Second XiangYa Hospital Of Central University

Changsha, China
The Secong People's Hospital Of HeFei

Hefei, China
The Secong People's Hospital Of HuNan Province

Changsha, China
The Third Hospital of Hebei Medical University

Shijiazhuang, China
The affilated hospital of qingdao university

Qingdao, China
Tianjin Huanhu Hospital

Tianjin, China
Tianjin Mental Health Center

Tianjin, China
WuXi People's Hospital

Wuxi, China
Wuhan Mental Health Centre

Wuhan, China
XianYang Hospital OF Yan'an University

Xianyang, China
Xiangya Hospital Central South University

Changsha, China
XuZhou Central Hospital

Xuzhou, China
Xuanwu Hospital Capital Medical University

Beijing, China
ZhenJiang Mental Health Center

Zhenjiang, China
ZhenZhou Central Hospital

Zhengzhou, China
Zhongda Hospital Southeast Unveristy

Nanjing, China
ZhuMaDian Second People's Hospital

Zhumadian, China
ZiGong First People's Hospital

Zigong, China

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