Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis

NCT07830303 | Not Yet Recruiting Phase 4

• 1 other identifier: SKLSIM-F-2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Daridorexant; Sleep Disturbance; Liver Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Percent Improvement From Baseline in Sleep Efficiency at Day 30

  Sleep efficiency (SE) measured by overnight polysomnography (PSG). The primary endpoint is the percent improvement in sleep efficiency from baseline to Day 30.

  Baseline and Day 30

Secondary Outcomes (9)

• Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at Day 30

  Baseline and Day 30

• Change From Baseline in Sleep Latency at Day 30

  Baseline and Day 30

• Change From Baseline in Total Sleep Time at Day 30

  Baseline and Day 30

• Change From Baseline in SWS/REM Sleep Ratio at Day 30

  Baseline and Day 30

• Change From Baseline in Microarousal Frequency at Day 30

  Baseline and Day 30

Study Arms (2)

Daridorexant

EXPERIMENTAL

Participants will receive daridorexant orally for 30 days. The dose will be 25 mg or 50 mg once daily according to liver function.

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally for 30 days.

Drug: Placebo

Interventions

Daridorexant DRUG

Daridorexant tablets administered orally once daily for 30 days. The dose is 25 mg or 50 mg according to liver function.

Daridorexant

Placebo DRUG

Matching placebo administered orally once daily for 30 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wang Fengmei: lead

Study Sites (3)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Parasomnias; Hepatic Encephalopathy

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Fengmei Wang

CONTACT

15522242696; wangfengmeitj@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)