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New drug aims to lift fatigue and brain fog in liver disease patients

NCT ID NCT07304843

Symptom relief Sponsor: Umecrine Cognition AB 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests a drug called golexanolone in 84 people with primary biliary cholangitis (PBC) who suffer from significant fatigue and cognitive problems. Participants receive either the drug or a placebo for up to 28 days. The goal is to see if the drug is safe and can improve quality of life, including tiredness and mental clarity.

What this could mean

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

Active substance
golexanolone
What this could lead to
If it works, this could point toward a treatment that eases fatigue and brain fog in people with primary biliary cholangitis.
What could go wrong
This is an early phase 1b/2 trial with only 84 people, so results may not apply broadly. The drug may not improve symptoms or could cause side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Male and female subjects age ≥ 18 years * Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics * Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening * Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening * Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation * For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of IMP * WOCBP must be willing to use a contraceptive method with a failure rate of \< 1% and agree to continue use of this method for the duration of the study and thereafter for 1 month after the last dosing of the IMP * Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal * Fertile male subjects must be willing to use condom and assure that their female partner will use contraceptive methods with a failure rate of \< 1% * Willing and able to give informed consent * The subject should be judged by the Investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent Exclusion Criteria: * Child-Pugh class B or C cirrhosis * Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding) * History of hepatocellular carcinoma * Bilirubin \>1.5 x ULN * Glomerular filtration rate (GFR) \<35 mL/min/1.73m2 * Low Haemoglobin (HB), i.e. subjects with moderate/severe anaemia * Low S-B12 or low P-folate * Evidence of biliary obstruction * Any positive result on screening for human immunodeficiency virus (HIV), or hepatitis B (serum hepatitis B surface antigen positive) * Prolonged QTcF (\>500 ms), or any clinically significant abnormality in the resting ECG, as judged by the Investigator (at screening) * Concomitant disease characterised by chronic fatigue and/or cognitive impairment * Clinically significant bowel disease, including obstruction, active inflammatory bowel disease, or malabsorption * Clinically significant sleep apnoea * An uncontrolled thyroid disorder * Subjects with a history of or currently active immune disorders (i.e. uncontrolled) other that PBC (including autoimmune disease) and/or diseases requiring immunosuppressive drugs * Clinical diagnosis of autoimmune hepatitis overlap * The presence, as judged by the Investigator, of clinically significant concomitant illness which would jeopardise safe participation in the study and /or the interpretation of study findings * Regular use of prescribed or over the counter (OTC) medications known to cause fatigue or cognitive dysfunction * Use of prohibited medications within 14 days prior to randomisation * Anticipated change in PBC medication and/or significant medical or surgical intervention within the duration of the study * Regular (more than 1 week per month) alcohol consumption in excess of 14 units per week * Administration of another new chemical entity or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study * Females who are pregnant, nursing or actively trying to conceive a child * Expected inability to swallow the required number of IMP capsules at the applicable dose level * History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator

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Conditions

The condition(s) this trial relates to.

Fatigue primary biliary cholangitis

As listed by the trial registrant

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

Primary biliary cholangitis (PBC)

Contacts and locations

Locations

  • 9 Eylul University Research and Application Hospital Department of Gastroenterology

    Balçova, 35340, Turkey (Türkiye)

  • A. Gemelli Polyclinic, Sacro Cuore Catholic University

    Roma, 168, Italy

  • Dept of Gastroenterology & Hepatology Portsmouth Hospitals University NHS Trust Queen Alexandra Hospital

    Portsmouth, PO6 3LY, United Kingdom

  • Dicle University Faculty of Medicine Department of Gastroenterology

    Diyarbakır, 21280, Turkey (Türkiye)

  • Ege University Faculty of Medicine, Department of Gastroenterology

    Izmir, 35100, Turkey (Türkiye)

  • Facility of CRU Hungary Ltd.

    Kistarcsa, 2143, Hungary

  • Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF, United Kingdom

  • Guy's and St Thomas' Hospital, London

    London, SE1 7EH, United Kingdom

  • Hacettepe University, Fakulty of Medicine, Department of Gastroenterology and Hepatology

    Ankara, 06230, Turkey (Türkiye)

  • Harran Üniversitesi Osmanbey Campus Department of Gastroenterology

    Sanliurfa, 63300, Turkey (Türkiye)

  • Hippokration General Hospital of Athens

    Athens, 11527, Greece

  • Hospital 12th October, Madrid

    Madrid, 28041, Spain

  • Hospital Clinic Barcelona

    Barcelona, 8036, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitario Parc Taulí

    Barcelona, 08208, Spain

  • Hospital Universitario Virgen De La Victoria

    Málaga, 29010, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026, Spain

  • Humanitas University

    Rozzano, 20089, Italy

  • Karadeniz Technical University, Farabi Hospital, Department of Gastroenterology

    Trabzon, 61080, Turkey (Türkiye)

  • Kocaeli University Faculty of Medicine Gastroenterology and Hepatology Department

    Kocaeli, 41100, Turkey (Türkiye)

  • NIHR Birmingham BRC

    Birmingham, B15 2TT, United Kingdom

  • Nottingham Digestive Diseases Centre and Biomedical Research Centre Nottingham University Hospitals NHS Trust, Queen's Medical Centre

    Nottingham, NG7 2UH, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, United Kingdom

  • Recep Tayyip Erdoğan University Training and Research Hospital, Department of Gastroenterology

    Rize, 53020, Turkey (Türkiye)

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Royal Wolverhampton NHS Trust, New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • University Hospital Complex of Pontevedra & IIS Galicia South, Pontevedra

    Pontevedra, 36071, Spain

  • University Hospital Düsseldorf

    Düsseldorf, 40225, Germany

  • University Hospital Marquez de Valdecilla, Santander

    Santander, 39008, Spain

  • University Hospital Paolo Giaccone, University of Palermo

    Palermo, 90127, Italy

  • University Hospital of Patras

    Pátrai, 26504, Greece

  • University Medical Center "Zvezdara"

    Belgrade, 11000, Serbia

  • University of Leipzig

    Leipzig, 04103, Germany

  • University of Padova, Department of Surgery, Oncology and Gastroenterology

    Padova, 35128, Italy

  • University of Udine

    Udine, 33100, Italy

  • Università di Milano-Bicocca, S.C. ASST Grande Ospedale Metropolitano Niguarda, Dipartimento di Medicina e Chirurgia, Epatologia e Gastroenterologia

    Milan, 20162, Italy

  • Virgen del Rocio University Hospital

    Seville, 41013, Spain

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