Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder
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
1 other identifier
interventional
1,037
1 country
83
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedJune 30, 2026
June 1, 2026
1.6 years
August 24, 2022
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
from baseline to day 14
Secondary Outcomes (20)
Change from baseline in the subjective sleep efficiency (sSE) after 7 days of treatment
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
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
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
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
Baseline, week 1, week 2
- +15 more secondary outcomes
Study Arms (3)
YZJ-1139 20mg
EXPERIMENTALYZJ-1139 40mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- 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:
- 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.
You may not qualify if:
- 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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
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
China-Japan Friendship Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
The First affiliated hospital of bengbu medical college
Bengbu, China
Binzhou Medical University Hospital
Binzhou, China
The First Bethune Hospital Of Jilin University
Changchun, China
The First Hospital of ChangSha
Changsha, China
The Second XiangYa Hospital Of Central University
Changsha, China
The Secong People's Hospital Of HuNan Province
Changsha, China
Xiangya Hospital Central South University
Changsha, China
The Fourth People's Hospital Of ChengDu
Chengdu, China
Army Medical Center of PLA
Chongqing, 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
People's Hospital Of DeYang City
Deyang, China
The First Affiliated Hospital Of FuJan Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
The Affiliated Hospital Of GuiZhou Medical University
Guiyang, China
HanDan Central Hospital
Handan, China
Affiliated HangZhou First People's Hospital
Hangzhou, China
Sir Run Run Shaw hospital
Hangzhou, China
The 2nd Affiliated Hospital Of Harbin Medical University
Ha’erbin, China
Chaohu hospital of anhui medical university
Hefei, China
The Second Hospital Of AnHui Medical University
Hefei, China
The Secong People's Hospital Of HeFei
Hefei, China
Affiliated NanHua Hospital,University Of South China
Hengyang, China
JiangMen Central Hospital
Jiangmen, China
ShanDong Provincial QianFoShan Hospital
Jinan, China
Jingjiang People's Hospital
Jingjiang, China
Shandong Daizhuang Hospital
Jining, China
Jiujiang University Affiliated Hospital
Jiujiang, China
First People's Hospital of Yunnan Province
Kunming, China
LiaoCheng People's Hospital
Liaocheng, China
HeNan University Of Science &Technology
Luoyang, China
The Affiliated Hospital Of Southwest Medical University
Luzhou, China
JiangXi Provincial People's Hospital
Nanchang, China
The First Affiliated Hospital Of NanChang University
Nanchang, China
The Second Affiliated Hospital Of NanChang University
Nanchang, China
Zhongda Hospital Southeast Unveristy
Nanjing, China
NanTong First People's Hospital
Nantong, China
NingBo KangNing Hospital
Ningbo, China
NingBo Medical Center LiHuiLi Hospital
Ningbo, China
QingDao Center Medical Group
Qingdao, China
QingDao Municipal Hospital
Qingdao, China
The affilated hospital of qingdao university
Qingdao, China
The 2nd Affiliated Hospital Of FuJan Medical University
Quanzhou, China
Affiliated ZhongShan Hospital,University Of FuDan
Shanghai, China
HuaShan Hospital Fudan University
Shanghai, China
ShengJing Hospital Of China Medical University
Shenyang, China
ShenZhen People's Hospital
Shenzhen, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
The Third Hospital of Hebei Medical University
Shijiazhuang, China
Jilin Neuropsychiatric Hospital
Siping, China
SuZhou GuangJi Hospital
Suzhou, China
The First People's Hospital Of KunShan
Suzhou, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
First Hospital Of ShanXi Medical University
Taiyuan, China
Peking University BinHai Hospital
Tianjin, China
Tianjin Huanhu Hospital
Tianjin, China
Tianjin Mental Health Center
Tianjin, China
The Center Hospital of WuHan
Wuhan, China
Wuhan Mental Health Centre
Wuhan, China
Affiliated Hospital Of Jiangnan University
Wuxi, China
WuXi People's Hospital
Wuxi, China
Air Force Medical University
Xi'an, China
XianYang Hospital OF Yan'an University
Xianyang, China
HeNan Mental Hospital
Xinxiang, China
The Affiliated Hospital Of XuZhou Medical University
Xuzhou, China
XuZhou Central Hospital
Xuzhou, China
The First Affiliated Hospital Of ZhenZhou University
Zhengzhou, China
ZhenZhou Central Hospital
Zhengzhou, China
ZhenJiang Mental Health Center
Zhenjiang, China
ZhuMaDian Second People's Hospital
Zhumadian, China
ZiGong First People's Hospital
Zigong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 24, 2022
First Posted
September 1, 2022
Study Start
December 17, 2021
Primary Completion
July 7, 2023
Study Completion
September 27, 2023
Last Updated
June 30, 2026
Record last verified: 2026-06