Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05480696 Sponsor: McMaster University Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05480696
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:

  • Children between the ages of 8 and 17 years old
  • Children who have been diagnosed with obesity, based on a body weight measurement (BMI) that is significantly above the average for their age and sex according to World Health Organization charts
  • Children who are already enrolled in the GHWM Clinic
  • Children who have signs of a liver condition called fatty liver disease, shown by an elevated liver enzyme level on a blood test and fat buildup in the liver detected during clinic assessment

Who may not be able to join:

  • Children who have been diagnosed with Type 1 or Type 2 diabetes
  • Children who cannot have an MRI scan — for example, due to fear of enclosed spaces, having a metal implant in their body, a recent tattoo, or weighing more than 300 pounds
  • Children who are currently taking other fibre supplements
  • Children who have taken certain medications in the past year that are known to affect fat levels in the liver, such as steroids, some seizure medications, some mental health medications, or blood sugar-lowering medications (confirm with trial site for the full list)
  • Children who have another known cause of liver disease other than fatty liver
  • Children who have a known allergy or sensitivity to the fibre supplement being used in this trial (called OF-INU)
  • Children whose reported alcohol intake is more than 7 drinks per week or more than 3 drinks in a single day

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 27 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: Nikhil Pai, MD, McMaster University

Phone: 3063611281

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
McMaster University
Registry
ClinicalTrials.gov
Start date
9 September 2022
Est. completion
1 March 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Change in hepatic fat content.

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: 27 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