Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT07679542 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT07679542
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:

  • People aged 18 to 45 years of any gender.
  • People who have been diagnosed with Metabolic Associated Fatty Liver Disease (MAFLD), which requires evidence of fat in the liver shown by at least one of: an ultrasound, CT scan, or MRI showing liver fat of 5% or more; a liver biopsy taken within the last 6 months confirming fat in the liver of 5% or more; or a FibroScan result (a specific liver measurement) at or above a certain threshold (confirm with trial site).
  • People who also have at least one sign of metabolic health issues, such as: a higher-than-average body weight or waist size; elevated blood pressure or being on blood pressure medication; pre-diabetes, Type 2 diabetes, or certain elevated blood sugar readings; high levels of fats called triglycerides in the blood, or being on cholesterol-lowering medication; or low levels of "good" (HDL) cholesterol, or being on cholesterol-lowering medication.
  • People who take medications for blood sugar, blood pressure, or cholesterol must have been on a stable, unchanged dose for at least 3 months before the trial screening.
  • People whose body weight has been stable — meaning it has not changed by more than 5% — in the 3 months before screening and between screening and enrolment.
  • People who are willing to take part voluntarily, attend follow-up appointments, and sign a consent form.

Who may not be able to join:

  • People with significant liver function problems, based on specific blood test results being more than twice (or in some cases 1.5 times) the normal upper limit (confirm with trial site).
  • People who have used certain medications known to cause liver fat or scarring — such as steroids, valproate, methotrexate, tamoxifen, amiodarone, or oral vitamin E — for more than 2 weeks in the past year.
  • People who drink a large amount of alcohol each week — above certain limits depending on gender (confirm with trial site for exact amounts).
  • People who test positive for Hepatitis B or Hepatitis C.
  • People who have certain other liver conditions or health conditions that can themselves cause a fatty liver, such as autoimmune hepatitis, Wilson's disease, inflammatory bowel disease, coeliac disease, an underactive thyroid, or several other specific conditions (confirm with trial site for the full list).
  • People with a history of low white blood cell counts (a condition affecting the immune system).
  • People who have had weight-loss (bariatric) surgery within the past 2 years.
  • People who are pregnant, planning to become pregnant, or currently breastfeeding.
  • People with a history of cancer, heart disease, chronic kidney disease, advanced liver scarring with complications, or a liver transplant.
  • People who have taken any antibiotics within the 2 weeks before joining the trial.
  • People whom the clinical investigator considers unsuitable for the study for any reason.

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 23 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

Phone: 86-025-68303211

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 March 2026
Est. completion
30 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF)

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: 23 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