Low-Dose Pioglitazone for NASH in Type 2 Diabetes (AIM 2)
This study is testing a lower dose of pioglitazone (15 mg per day) for people with type 2 diabetes and nonalcoholic steatohepatitis (NASH). Pioglitazone is a drug already approved to help manage high blood sugar in type 2 diabetes. Researchers want to see if this lower dose can improve liver health in people with NASH. You would receive either pioglitazone or a placebo, which looks the same but has no active drug. The study will look for improvements in your liver health without worsening scarring (fibrosis) after 72 weeks of treatment. This study is currently unclear on its recruitment status and plans to enroll 166 participants aged 21 to 75 years.
- Study design
- This is a single-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of pioglitazone. It is a Phase 2A study and plans to enroll 166 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 72 weeks of treatment, indicating follow-up during this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low-Dose Pioglitazone in Patients With NASH (AIM 2)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kenneth Cusi, MD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
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What this trial measures
- The proportion of pioglitazone-treated patients relative to placebo achieving an improvement of ≥2 points in non-alcoholic fatty liver disease activity score (NAS) without an increase in fibrosis stage.72 weeks of treatment
The proportion of patients with liver histological improvement of ≥2 points in non-alcoholic fatty liver disease activity score (NAS) with a ≥1-point reduction in either ballooning or lobular inflammation and no increase in fibrosis stage by NASH CRN scoring criteria.