Clinical Trial

Low-Dose Pioglitazone in Patients With NASH (AIM 2)

Recruiting Phase 2
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Summary
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-08-05; most recent amendment 2025-04-02.
Status change: Not Yet Recruiting → Recruiting 2021-01-11
Trial Details
NCT Number NCT04501406
Lead Sponsor University of Florida
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 2 Diabetes Mellitus (T2DM), Nonalcoholic Steatohepatitis
Enrollment 166 participants
Start Date 2020-12-15
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-04