NCT05525637 is a Phase 3 clinical trial of YZJ-1139 20mg in Insomnia Disorder, sponsored by Shanghai Haiyan Pharmaceutical Technology Co., Ltd..

Who is sponsoring NCT05525637?

NCT05525637 is sponsored by Shanghai Haiyan Pharmaceutical Technology Co., Ltd..

What drugs are being tested in NCT05525637?

Interventions in NCT05525637: YZJ-1139 20mg, YZJ-1139 40mg, Placebo.

What condition does NCT05525637 study?

NCT05525637 studies Insomnia Disorder.

Is NCT05525637 still recruiting?

NCT05525637 is currently status unknown. Last updated 17 April 2024.

Last reviewed 2024-04-17 · How we verify

NCT05525637

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 17 April 2024

What this trial tests

Phase 3 trial testing YZJ-1139 20mg in Insomnia Disorder in 1,041 participants. Status unknown.

Timeline

17 December 2021

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,041
Start date	17 December 2021
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	88 locations across China

Drugs / interventions tested

YZJ-1139 20mg — full drug profile →
YZJ-1139 40mg — full drug profile →
Placebo

Conditions studied

Insomnia Disorder — all drugs for Insomnia Disorder →

Sponsor

Shanghai Haiyan Pharmaceutical Technology Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Insomnia Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Hypocretin: a promising target for the regulation of homeostasis.
Wang Y, Fu S, Mao J, Cui K, et al · · 2025 · cited 2× · PMID 40927422 · DOI 10.3389/fnins.2025.1638270

Verify or expand the search:

Other trials of YZJ-1139 20mg

Trials testing the same drug.

NCT06680505 — Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder · Phase 2 · completed

Other recruiting trials for Insomnia Disorder

Currently open trials in the same condition.

NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study · NA · active not recruiting
NCT06669507 — The Sleep Clinic Outcome and Practice Study · NA · recruiting
NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia · NA · recruiting
NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease · Phase 4 · recruiting

Other Shanghai Haiyan Pharmaceutical Technology Co., Ltd. trials

Trials by the same sponsor.

NCT06671444 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment · Phase 1 · active not recruiting
NCT06671509 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment · Phase 1 · completed
NCT06681493 — A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects · Phase 1 · completed
NCT06680505 — Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder · Phase 2 · completed
NCT06685341 — PK/PD Study of YZJ-1139 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05525637 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Last refreshed: 17 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05525637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing