Liver CirrhosisPhase 4NCT07830303
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
A Phase 4 study testing Daridorexant in people with Liver Cirrhosis and Sleep Disturbance, run by Wang Fengmei at 3 sites in China.
Trial summary
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis, Sleep Disturbance, Hepatic Encephalopathy
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2026to Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis.
- Child-Pugh class A or B liver function; participants with hepatic encephalopathy must have covert hepatic encephalopathy (minimal hepatic encephalopathy [MHE]) or West-Haven grade I hepatic encephalopathy.
- Insomnia supported by both subjective and objective evidence, including a Pittsburgh Sleep Quality Index (PSQI) total score >5 and objective polysomnography (PSG) or actigraphy findings.
- Provision of written informed consent.
Who cannot join
- Age <18 years or >60 years.
- Child-Pugh class C liver function.
- Overt hepatic encephalopathy of West-Haven grade II or higher.
- Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin.
- Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea.
- Pregnancy or breastfeeding.
Show all 11Show fewer
- Narcolepsy.
- Known hypersensitivity to daridorexant or any of its excipients.
- Concomitant use of central nervous system depressants, including alcohol, benzodiazepines, or opioids, that may increase sedation or somnolence.
- Active severe psychiatric disorders, such as depression with suicidal ideation or a history of suicidal ideation, or a history of substance abuse.
- Any contraindication to daridorexant.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192
Fengmei Wang, 15522242696, wangfengmeitj@126.com
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Fengmei Wang, 15522242696, wangfengmeitj@126.com
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality
Fengmei Wang, 15522242696, wangfengmeitj@126.com
About this study
Official title: Efficacy and Safety of a Novel Dual Orexin Receptor Antagonist in Patients With Sleep Disturbance and Hepatic Encephalopathy
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.
- Conditions
- Liver Cirrhosis, Sleep Disturbance, Hepatic Encephalopathy
- Being tested
- Daridorexant, Placebo
- Keywords
- Daridorexant, Sleep Disturbance, Liver Cirrhosis, Hepatic Encephalopathy
- Medical subject headings
- Liver Cirrhosis, Parasomnias, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant tablets administered orally once nightly for 30 days at a dose of 25 mg or 50 mg according to liver function and the study protocol. The maximum dose for participants with Child-Pugh class B liver function is 25 mg per night.
PlaceboDrug
Matching placebo administered orally once daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | Participants will receive oral daridorexant once nightly for 30 days. The dose will be 25 mg or 50 mg according to liver function and the study protocol. For participants with Child-Pugh class B liver function, the dose will not exceed 25 mg per night. Receives: Drug: Daridorexant |
| Placebo | Placebo comparator | Participants will receive matching placebo orally for 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Improvement From Baseline in Sleep Efficiency at Day 30
Sleep efficiency (SE) is measured by overnight polysomnography (PSG) and expressed as the percentage of time in bed spent asleep. PSG is performed at baseline and on Days 7, 14, and 30. The primary outcome is the relative percent change in SE from baseline to Day 30.
Measured: Baseline and Day 30
Secondary outcomes (15)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at Day 30
The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in the PSQI total score from baseline to Day 30.
Measured: Baseline and Day 30
Change From Baseline in Polysomnography-Measured Sleep Latency at Day 30
Sleep latency is measured by overnight polysomnography (PSG), in minutes, from lights out to sleep onset. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is calculated as Day 30 sleep latency minus baseline sleep latency; negative values indicate a shorter time to fall asleep.
Measured: Baseline and Day 30
Change From Baseline in Total Sleep Time at Day 30
Total sleep time is the total duration of sleep recorded during overnight polysomnography (PSG), expressed in minutes. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is calculated as Day 30 total sleep time minus baseline total sleep time; positive values indicate a longer sleep duration.
Measured: Baseline and Day 30
Change From Baseline in Slow-Wave Sleep Percentage at Day 30
Slow-wave sleep (SWS) is defined as stage N3 sleep measured by overnight polysomnography (PSG). SWS percentage is calculated as N3 sleep time divided by total sleep time, multiplied by 100. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is the Day 30 SWS percentage minus the baseline SWS percentage, expressed in percentage points.
Measured: Baseline and Day 30
Change From Baseline in Rapid Eye Movement Sleep Percentage at Day 30
Rapid eye movement (REM) sleep is measured by overnight polysomnography (PSG). REM sleep percentage is calculated as REM sleep time divided by total sleep time, multiplied by 100. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is the Day 30 REM sleep percentage minus the baseline REM sleep percentage, expressed in percentage points.
Measured: Baseline and Day 30
Change From Baseline in Microarousal Frequency at Day 30
Measured: Baseline and Day 30
Change From Baseline in Psychometric Hepatic Encephalopathy Score During Treatment
The Psychometric Hepatic Encephalopathy Score (PHES) ranges from -15 to +5, with higher scores indicating better cognitive performance. The outcome is the change in PHES during the study.
Measured: Baseline, Day 7, Day 14, and Day 30
Change From Baseline in Stroop EncephalApp Performance at Day 30
Measured: Baseline and Day 30
Change From Baseline in Epworth Sleepiness Scale Total Score at Day 30
Measured: Baseline and Day 30
Proportion of Participants With Reversal of Minimal Hepatic Encephalopathy by Day 30
Measured: Baseline through Day 30
Proportion of Participants With New-Onset Minimal Hepatic Encephalopathy Through Day 30
Measured: Baseline through Day 30
Incidence of Overt Hepatic Encephalopathy by Day 30
Measured: From baseline through Day 30
Proportion of Participants With Adverse Events
Measured: From treatment initiation through Day 30
Proportion of Participants With Serious Adverse Events
Measured: From treatment initiation through Day 30
Proportion of Participants Discontinuing Study Treatment Due to Adverse Events
Measured: From treatment initiation through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Fengmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Fengmei, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830303
- Sponsor's protocol ID
- SKLSIM-F-2025
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel Dual Orexin Receptor Antagonist in Patients With Sleep Disturbance and Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT07830303
- Acronym / sponsor ID
- SKLSIM-F-2025
- Conditions
- Liver Cirrhosis, Sleep Disturbance, Hepatic Encephalopathy
- Keywords
- Daridorexant, Sleep Disturbance, Liver Cirrhosis, Hepatic Encephalopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Wang FengmeiUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 21 Sep 2026 (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.
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: DaridorexantParticipants will receive oral daridorexant once nightly for 30 days. The dose will be 25 mg or 50 mg according to liver function and the study protocol. For participants with Child-Pugh class B liver function, the dose will not exceed 25 mg per night. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo orally for 30 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years.
- Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis.
- Child-Pugh class A or B liver function; participants with hepatic encephalopathy must have covert hepatic encephalopathy (minimal hepatic encephalopathy [MHE]) or West-Haven grade I hepatic encephalopathy.
- Insomnia supported by both subjective and objective evidence, including a Pittsburgh Sleep Quality Index (PSQI) total score >5 and objective polysomnography (PSG) or actigraphy findings.
- Provision of written informed consent.
Key exclusion criteria (11 listed)
- Age <18 years or >60 years.
- Child-Pugh class C liver function.
- Overt hepatic encephalopathy of West-Haven grade II or higher.
- Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin.
- Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea.
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 |
|---|---|---|
| DaridorexantDaridorexant tablets administered orally once nightly for 30 days at a dose of 25 mg or 50 mg according to liver function and the study protocol. The maximum dose for participants with Child-Pugh class B liver function is 25 mg per night. | Drug | Daridorexant |
| PlaceboMatching placebo administered orally once daily for 30 days. | Drug | Placebo |
Primary outcome
Percent Improvement From Baseline in Sleep Efficiency at Day 30
Time frame: Baseline and Day 30
Sleep efficiency (SE) is measured by overnight polysomnography (PSG) and expressed as the percentage of time in bed spent asleep. PSG is performed at baseline and on Days 7, 14, and 30. The primary outcome is the relative percent change in SE from baseline to Day 30.
15 secondary outcomes
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Polysomnography-Measured Sleep Latency at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Total Sleep Time at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Slow-Wave Sleep Percentage at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Rapid Eye Movement Sleep Percentage at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Microarousal Frequency at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Psychometric Hepatic Encephalopathy Score During Treatment
Time frame: Baseline, Day 7, Day 14, and Day 30
Change From Baseline in Stroop EncephalApp Performance at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Epworth Sleepiness Scale Total Score at Day 30
Time frame: Baseline and Day 30
Proportion of Participants With Reversal of Minimal Hepatic Encephalopathy by Day 30
Time frame: Baseline through Day 30
Proportion of Participants With New-Onset Minimal Hepatic Encephalopathy Through Day 30
Time frame: Baseline through Day 30
Incidence of Overt Hepatic Encephalopathy by Day 30
Time frame: From baseline through Day 30
Proportion of Participants With Adverse Events
Time frame: From treatment initiation through Day 30
Proportion of Participants With Serious Adverse Events
Time frame: From treatment initiation through Day 30
Proportion of Participants Discontinuing Study Treatment Due to Adverse Events
Time frame: From treatment initiation through Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daridorexant in people with Liver Cirrhosis and Sleep Disturbance, run by Wang Fengmei at 3 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengmei Wang (15522242696, wangfengmeitj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Improvement From Baseline in Sleep Efficiency at Day 30 (time frame: Baseline and Day 30). 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 16 Oct 2026.