Phase 4 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05305287 Sponsor: The University of Texas Health Science Center at San Antonio Condition: Non-Alcoholic Fatty Liver Disease
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Phase 4 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05305287
Recruiting Phase 4

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 who have been confirmed to have type 2 diabetes based on a specific blood sugar test (a 2-hour glucose test showing levels of 200 mg/dl or higher).
  • People whose diabetes is managed with diet, metformin, and/or a type of medication called a sulfonylurea, and who are in good general health.
  • People aged between 18 and 80 years old.
  • People with a body mass index (BMI) between 25 and 40.
  • People whose long-term blood sugar control measure (HbA1c) is between 7% and 10%.
  • People whose body weight has been stable (within about 4 pounds) over the past 3 months.
  • People who are not taking any medications that are known to affect blood sugar levels, other than their diabetes medications.
  • People with moderate to severe fatty liver disease, confirmed by specific liver scans (FibroScan and MRI), with either no or minimal liver scarring (for the fatty liver without inflammation group), or moderate to severe liver scarring (for the fatty liver with inflammation group).

Who may not be able to join:

  • People who drink more than 14 units of alcohol per week (for women) or more than 21 units per week (for men).
  • People who have advanced liver scarring known as cirrhosis (stage 4 fibrosis).
  • People who have type 1 diabetes, or who test positive for a specific antibody called GAD.
  • People who are new to diabetes medication or who have been taking metformin for more than 3 months (confirm with trial site).
  • People who have a serious eye complication of diabetes called proliferative retinopathy.
  • People whose urine shows high levels of a protein called albumin, above 300 mg per day, which can indicate kidney problems.
  • People who have another form of chronic liver disease, such as alcoholic liver disease, hepatitis B or C, primary biliary cholangitis, suspected or confirmed liver cancer, or any liver disease other than fatty liver disease (NAFLD/NASH).
  • People who have been diagnosed with severe heart failure (classified as New York Heart Association Class III or IV).

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Luke Norton, PhD, The University of Texas Health Science Center at San Antonio

Phone: 210-567-0739

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 4
Sponsor
The University of Texas Health Science Center at San Antonio
Registry
ClinicalTrials.gov
Start date
1 November 2022
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes

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: 28 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