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New sleep drug shows promise for liver patients

NCT ID NCT07480096

Symptom relief Sponsor: Indonesia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a sleep medication called lemborexant in 82 adults with liver cirrhosis who had trouble sleeping. The drug works by blocking wakefulness signals in the brain. Researchers measured sleep quality and checked for side effects on the liver. The goal was to see if lemborexant is a safe and effective option for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lemborexant
What this could lead to
If it works, this could offer a safer sleep medication for people with liver cirrhosis, improving their quality of life without harming the liver.
What could go wrong
This is a small, early-phase trial (82 participants). The results may not apply to all cirrhosis patients, and long-term safety is not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

82 people

The number who actually took part.

Started

Oct 2024

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adults aged 18 years or older; * willingness to participate in the clinical trial as evidenced by written informed consent; documented diagnosis of liver cirrhosis in the medical record, with disease severity assessed using the Child-Pugh score and supported by imaging findings consistent with cirrhosis on FibroScan or ultrasonography; * presence of sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score greater than 5; * patients receiving inpatient or outpatient care at Cipto Mangunkusumo National General Hospital; * ability to take oral medication; * willingness of the patient or caregiver to maintain a sleep diary throughout the study period; * ability of the patient or caregiver to comply with the clinical trial protocol and complete scheduled serial assessments. Exclusion Criteria: * advanced liver cirrhosis defined as Child-Pugh class C; * current use of medications with significant interactions affecting the metabolism of Lemborexant, including itraconazole, clarithromycin, fluconazole, verapamil, tramadol, rifampicin, carbamazepine, bosentan, efavirenz, etravirine, and modafinil; * ongoing alcohol consumption or intake of grapefruit juice during the study period; * pregnancy, breastfeeding, or plans to become pregnant during the study; * presence of significant comorbid conditions such as autoimmune disease, * stage V chronic kidney disease, HIV/AIDS, or known or suspected hypersensitivity to the investigational drug; * concurrent participation in another clinical trial at the time of screening.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatic encephalopathy insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis Hepatic encephalopathy Insomnia Liver cirrhosis Sleep quality

Contacts and locations

Locations

  • Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta

    Jakarta, DKI Jakarta, 10430, Indonesia

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