Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT06461208 Sponsor: King's College London Condition: Non-Alcoholic Fatty Liver Disease
Back to Non Alcoholic Fatty Liver Disease

Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT06461208
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older
  • You have been diagnosed with liver cirrhosis caused by alcohol use, a condition called MASLD (fat-related liver disease), or a combination of both, confirmed by medical tests, scans, or a liver biopsy
  • Your liver disease is rated at a moderate severity level, based on a score called MELD, which falls between 8 and 16
  • If your cirrhosis is related to alcohol, you are currently drinking on average no more than 20 grams of alcohol per day (roughly 2.5 units or less)
  • You are able to understand the study and give your written agreement to take part

Who may not be able to join:

  • You have a moderate, severe, or life-threatening food allergy (for example, a peanut allergy)
  • You are pregnant, planning to become pregnant, or currently breastfeeding
  • You have been treated for serious liver-related complications — such as internal bleeding, a severe infection, confusion caused by liver disease, or sudden liver failure — within the last 14 days
  • You drink more than 20 grams of alcohol per day on average (roughly more than 2.5 units per day)
  • You have previously had a liver transplant
  • You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
  • You have coeliac disease (a condition where gluten damages the gut)
  • You have had previous stomach or bowel surgery that could affect the bacteria in your gut, such as a gastric bypass
  • You currently have any active cancer, including a type of liver cancer called hepatocellular carcinoma
  • Your life expectancy is less than 6 months, or you are already on a waiting list for a liver transplant
  • You are living with HIV, or have active hepatitis B or C (those with undetectable levels of the virus may still be eligible — confirm with trial site)
  • You have taken antibiotics or probiotic supplements within the last 7 days before joining the trial (note: everyday foods containing live bacteria, such as yoghurt, kefir, sauerkraut, kombucha, or cheese, do not count)
  • You have difficulty swallowing or are unlikely or unwilling to take the study medication
  • You have taken part in another clinical drug or device trial within the last 4 months
  • You have another medical, psychological, family, or social situation that the lead doctor feels could affect your health, your ability to follow the study, or the reliability of the results (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 020 7848 0532

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
21 June 2023
Est. completion
31 January 2028

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Defined infection resulting in presentation to the emergency department or hospital admission (time to event); Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov