Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT06332677 Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Condition: Non-Alcoholic Fatty Liver Disease
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Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT06332677
Recruiting Not Applicable

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 over 18 years old whose samples and data were already collected as part of one of three earlier studies (called SERENA, REASON, and MAFALDA), and who previously agreed to genetic analysis
  • People who agree to take part in this current study

From the SERENA study, people included were those who:

  • Had been diagnosed with a liver condition called NAFLD (fatty liver disease)
  • Were between 45 and 75 years old
  • Had at least one of the following: moderate to severe liver scarring (F3–F4 fibrosis or cirrhosis) confirmed by biopsy, blood tests, or imaging; a close family member (parent, sibling, or child) with a specific type of liver cancer; or carried rare gene changes linked to liver cancer risk; OR were male with type 2 diabetes or obesity and carried at least three specific genetic variants (confirm with trial site)

From the REASON study, people included were those who:

  • Were over 18 and had a liver biopsy for suspected fatty liver disease (NASH), OR had surgery involving liver tissue, OR had a liver transplant, OR had gallbladder removal surgery

From the MAFALDA study, people included were those who:

  • Had weight-loss (bariatric) surgery for severe obesity (BMI of 40 or above, or BMI 35–39 with related health conditions such as uncontrolled high blood pressure, diabetes, or high cholesterol)
  • Had no medical reasons preventing surgery
  • Agreed to sign a consent form

Who may not be able to join:

  • People who do not meet any of the inclusion criteria listed above
  • People who drink alcohol above a certain threshold (more than 30g per day for men or 20g per day for women)
  • People whose liver disease is caused by a viral infection, an autoimmune condition, or any other cause not related to the conditions described above

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 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Registry
ClinicalTrials.gov
Start date
1 March 2023
Est. completion
30 September 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

the main genes and expression by comparing the transcriptomic lipidomic profile; the main genes and expression by comparing the transcriptomic lipidomic profile

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: 22 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