Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder

NCT06975514 | Recruiting Phase 3

• 1 other identifier: YZJ-1139-3-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Baseline, Day 1/Day 2, Day 27/Day 28

Secondary Outcomes (10)

• Change from baseline of Mean Subject Wake After Sleep Onset (sWASO)

  Baseline, Week1, Week 4

• Change from baseline of Mean Subject Sleep Efficiency (sSE)

  Baseline, Week1, Week 4

• Change from baseline of Mean subject Total Sleep Time (sTST)

  Baseline, Week1, Week 4

• Change from baseline of Mean Subjective Time to Sleep Onset (sTSO)

  Baseline, Week1, Week 4

• Change from baseline of Mean Subjective Number of awakenings (sNAW)

  Baseline, Week1, Week 4

Study Arms (2)

YZJ-1139 group

EXPERIMENTAL

Drug: YZJ-1139

Zolpidem group

ACTIVE COMPARATOR

Drug: Zolpidem

Interventions

YZJ-1139 DRUG

YZJ-1139 20mg tablets, once daily in the evening

YZJ-1139 group

Zolpidem DRUG

Zolpidem 10mg tablets, once daily in the evening

Zolpidem group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.: lead

Study Sites (16)

Peking University People's Hospital

Beijing, China

RECRUITING

ChengDu Second People's Hospital

Chengdu, China

RECRUITING

ChongQing Traditional Chinese Medicine Hospital

Chongqing, China

RECRUITING

Deyang People's Hospital

Deyang, China

RECRUITING

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

Guangzhou, China

RECRUITING

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)

Jinan, China

RECRUITING

The Second Affiliated Hospital Of NanChang University

Nanchang, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, China

RECRUITING

ShengJing Hospital Of China Medical University

Shenyang, China

RECRUITING

The Third Hospital of Hebei Medical University

Shijiazhuang, China

RECRUITING

SuZhou GuangJi Hospital

Suzhou, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Tianjin Anding Hospital

Tianjin, China

RECRUITING

Wuhan No.1 Hospital

Wuhan, China

RECRUITING

Yan'an University Xianyang Hospital

Yan’an, China

RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: May 9, 2025
• First Posted: May 16, 2025
• Study Start: March 25, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-05

Locations

CN (16)