Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05935826 Sponsor: University of Colorado, Denver Condition: Non-Alcoholic Fatty Liver Disease
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Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05935826
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:

  • People aged 13 to 18 who are in the later stages of puberty (Tanner stage 4–5) (confirm with trial site)
  • People who have been suspected of having, or have been diagnosed with, a condition called non-alcoholic fatty liver disease (NAFLD), confirmed by a liver scan or liver tissue sample taken within the past 6 months, as long as they have not lost more than 5% of their body weight since then
  • People whose liver fat level, measured by a special type of MRI scan, is above 5.5%
  • People whose NAFLD diagnosis has been confirmed by a liver specialist (hepatologist)
  • People who do less than 3 hours per week of moderate exercise (such as jogging or swimming)
  • People whose body weight falls into the overweight or obese category for their age and gender, meaning their BMI is at or above the 85th percentile

Who may not be able to join:

  • People currently taking certain medications, including metformin, oral steroid medicines taken within the past 10 days, certain antipsychotic medicines, medicines that suppress the immune system, or HIV medications
  • People who are currently pregnant or breastfeeding, or who become pregnant during the study
  • People who have had a serious illness requiring a hospital stay within the past 60 days
  • People who have diabetes, indicated by a blood sugar marker (HbA1c) above 6.4%
  • People whose body weight falls below the overweight category for their age and sex (below the 85th percentile), or whose waist measurement is greater than 200 cm
  • People who have anaemia, indicated by a low haemoglobin level below 11 mg/dL
  • People who have been diagnosed with a major psychiatric or developmental condition that would affect their ability to give informed consent
  • People who have implanted metal devices in their body that are not safe for MRI scanning
  • People currently taking blood pressure medications
  • People who have a liver disease other than NAFLD, or whose liver enzyme levels (AST or ALT) are above 150 IU/L

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
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

Principal Investigator: Melanie Cree, MD, PhD, University of Colorado, Denver

Phone: 720-777-6984

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
18 June 2024
Est. completion
31 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Hepatic Fat Fraction

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