Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05821010 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05821010
Recruiting Phase 2

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 have been diagnosed with NASH (a type of fatty liver disease) confirmed by a liver biopsy taken no more than 32 weeks before the study screening, with specific scores for fat, inflammation, and scarring in the liver (confirm with trial site for exact score requirements)
  • You speak Dutch or English fluently
  • You are able to understand the study information and agree to take part

Who may not be able to join:

  • You have drunk significant amounts of alcohol (more than about 1–2 drinks per day on average) for more than 3 months in a row during the past year
  • You have severe liver scarring (cirrhosis) or liver cancer
  • You have hepatitis B or hepatitis C
  • You have an autoimmune liver condition (where the immune system attacks the liver)
  • You have Wilson's disease (a condition affecting copper in the body)
  • You have a condition called primary sclerosing cholangitis or primary biliary cholangitis (bile duct disorders)
  • You have alpha-1-antitrypsin deficiency or hemochromatosis (inherited conditions affecting the liver)
  • You have had a liver transplant in the past, or are currently on a waiting list for one
  • You are currently taking pre-, pro-, or synbiotics (gut health supplements)
  • You have taken antibiotics throughout the whole body (not just on the skin) in the 3 months before joining the trial
  • You are taking certain medications including tamoxifen, methotrexate, or amiodarone
  • You have had or are planning to have weight-loss (bariatric) surgery
  • You have diabetes currently being treated with a GLP-1 receptor agonist medication (a specific type of diabetes drug, confirm with trial site)
  • You have a bleeding disorder
  • You have certain abnormal blood clotting or platelet results at screening (confirm with trial site)
  • You are on blood-thinning or anti-clotting medication that cannot be temporarily stopped
  • You have had a major heart or stroke event (such as a heart attack or stroke) in the 6 months before screening
  • You have a long-term weakened immune system, for example due to recent chemotherapy or HIV with a low immune cell count
  • You have or have had a serious cancer, unless it was fully treated and in complete remission (some minor skin cancers may be exceptions — confirm with trial site)
  • You have a major surgery planned during the time the trial will be running (minor procedures may be acceptable — confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have any other condition that, in the doctor's opinion, could affect your safety or ability to take part in the study
  • You are currently taking part in another clinical trial

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 15 July 2026
Phase 2: approximately ~30% 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

Principal Investigator: A.G. Holleboom, MD, PhD, Amsterdam UMC

Phone: +31205661267

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 2
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
17 March 2023
Est. completion
20 February 2026

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Liver histology

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: 15 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