CirrhosisPhase 2NCT07480096
Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems
A Phase 2 study testing Lemborexant in people with Cirrhosis and Liver Cirrhosis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver Cirrhosis, Sleep Quality
- What is being tested?
- Lemborexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2024to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta
Jakarta, DKI Jakarta, 10430
About this study
Official title: Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems: a Randomized Clinical Trial
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.
Read the detailed description
Patients with liver cirrhosis frequently experience sleep-wake disturbances such as insomnia, delayed sleep onset, or fragmented sleep. These disturbances may contribute to neurocognitive dysfunction and precipitate hepatic encephalopathy. However, conventional hypnotics such as benzodiazepines may worsen encephalopathy and are generally avoided.
Lemborexant selectively antagonizes orexin receptors OX1R and OX2R, modulating sleep without profound respiratory suppression or GABAergic effects. This randomized, three-armed, double-blind placebo-controlled trial aims to determine whether lemborexant improves sleep quality in patients with cirrhosis while maintaining acceptable neurocognitive and safety outcomes.
- Conditions
- Cirrhosis, Liver Cirrhosis, Sleep Quality, Insomnia, Hepatic Encephalopathy
- Being tested
- Lemborexant, Placebo
- Keywords
- cirrhosis, liver, sleep, orexin, lemborexant, insomnia, sleep quality, safety, efficacy
- Medical subject headings
- Fibrosis, Liver Cirrhosis, Sleep Initiation and Maintenance Disorders, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Lemborexant 5 mg orally once nightly before bedtime/ Lemborexant 10 mg orally once nightly before bedtime,
PlaceboDrug
Matching placebo taken orally once nightly before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| 5 mg lemborexant | Experimental | Lemborexant 5 mg orally once nightly before bedtime Receives: Drug: Lemborexant |
| 10 mg lemborexant | Experimental | Lemborexant 10 mg orally once nightly before bedtime Receives: Drug: Lemborexant |
| Placebo | Placebo comparator | Placebo orally once nightly before bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
PSQI score
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (3)
Hepatic Encephalopathy - Stroop Test
Stroop Test Score
Measured: From enrollment to the end of treatment at 2 weeks
Liver function tests
Liver function tests including ALT, AST, and total bilirubin levels
Measured: From enrollment to the end of treatment at 2 weeks
Persistence of effects (sleep quality)
PSQI score
Measured: PSQI changes post-crossover at week 2 - week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rino Alvani Gani, Universitas Indonesia
- Investigators
- Rino Alvani Gani, Professor, Internist, MD, Principal investigator, Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, JakartaPitt Akbar, MD, Internist, Study director, Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480096
- Sponsor's protocol ID
- 24-11-1690
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including baseline characteristics, as well as efficacy and safety outcome measures.
Publications
Marjot T, Ray DW, Williams FR, Tomlinson JW, Armstrong MJ. Sleep and liver disease: a bidirectional relationship. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):850-863. doi: 10.1016/S2468-1253(21)00169-2. Epub 2021 Jul 15.
PubMed 34273289Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.
PubMed 32585700Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254.
PubMed 31880796Gani RA, Akbar P, Hasan I, Sulaiman AS, Lesmana CRA, Kurniawan J, Panjaitan SM, Dirjayanto VJ. Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial. Aliment Pharmacol Ther. 2026 Aug;64(4):458-470. doi: 10.1111/apt.70811. Epub 2026 Jul 7.
PubMed 42414855
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07480096
- Acronym / sponsor ID
- 24-11-1690
- Conditions
- Cirrhosis, Liver Cirrhosis, Sleep Quality, Insomnia, Hepatic Encephalopathy
- Keywords
- cirrhosis, liver, sleep, orexin, lemborexant, insomnia, sleep quality, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 18 Mar 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.
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.
Detailed description
Patients with liver cirrhosis frequently experience sleep-wake disturbances such as insomnia, delayed sleep onset, or fragmented sleep. These disturbances may contribute to neurocognitive dysfunction and precipitate hepatic encephalopathy. However, conventional hypnotics such as benzodiazepines may worsen encephalopathy and are generally avoided.
Lemborexant selectively antagonizes orexin receptors OX1R and OX2R, modulating sleep without profound respiratory suppression or GABAergic effects. This randomized, three-armed, double-blind placebo-controlled trial aims to determine whether lemborexant improves sleep quality in patients with cirrhosis while maintaining acceptable neurocognitive and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 mg lemborexant | Experimental | Drug: LemborexantLemborexant 5 mg orally once nightly before bedtime |
| 10 mg lemborexant | Experimental | Drug: LemborexantLemborexant 10 mg orally once nightly before bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally once nightly before bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| LemborexantLemborexant 5 mg orally once nightly before bedtime/ Lemborexant 10 mg orally once nightly before bedtime, | Drug | 10 mg lemborexant, 5 mg lemborexant |
| PlaceboMatching placebo taken orally once nightly before bedtime. | Drug | Placebo |
Primary outcome
Sleep quality
Time frame: From enrollment to the end of treatment at 2 weeks
PSQI score
3 secondary outcomes
Hepatic Encephalopathy - Stroop Test
Time frame: From enrollment to the end of treatment at 2 weeks
Liver function tests
Time frame: From enrollment to the end of treatment at 2 weeks
Persistence of effects (sleep quality)
Time frame: PSQI changes post-crossover at week 2 - week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 34273289Marjot T, Ray DW, Williams FR, Tomlinson JW, Armstrong MJ. Sleep and liver disease: a bidirectional relationship. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):850-863. doi: 10.1016/S2468-1253(21)00169-2. Epub 2021 Jul 15.
- Background: PubMed 32585700Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.
- Background: PubMed 31880796Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254.
- Derived from this study: PubMed 42414855Gani RA, Akbar P, Hasan I, Sulaiman AS, Lesmana CRA, Kurniawan J, Panjaitan SM, Dirjayanto VJ. Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial. Aliment Pharmacol Ther. 2026 Aug;64(4):458-470. doi: 10.1111/apt.70811. Epub 2026 Jul 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, including baseline characteristics, as well as efficacy and safety outcome measures.
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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. This study is not recruiting at the moment.
Rino Alvani Gani, Professor, Internist, MD principal investigator
Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta
Pitt Akbar, MD, Internist study director
Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant in people with Cirrhosis and Liver Cirrhosis, run by Universitas Indonesia at 1 site in Indonesia.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07480096, which also lists 4 linked publications.
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 18 Mar 2026.