NCT04501406

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

Recruiting now Phase 2 Last updated 4 April 2025

What this trial tests

Phase 2 trial testing Pioglitazone in Type 2 Diabetes Mellitus (T2DM) in 166 participants. Currently enrolling.

Timeline

15 December 2020

Primary endpoint
31 August 2027

31 August 2027

Quick facts

Lead sponsor	University of Florida
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	166
Start date	15 December 2020
Primary completion	31 August 2027
Estimated completion	31 August 2027
Sites	1 location across United States

Drugs / interventions tested

• Pioglitazone (pioglitazone) — full drug profile →
• Placebo

Conditions studied

• Type 2 Diabetes Mellitus (T2DM) — all drugs for Type 2 Diabetes Mellitus (T2DM) →
• Nonalcoholic Steatohepatitis — all drugs for Nonalcoholic Steatohepatitis →

Sponsor

University of Florida

Who can join

Adults 21 to 75, any sex, with Type 2 Diabetes Mellitus (T2DM) or Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NAFLD: Mechanisms, Treatments, and Biomarkers.
   Nassir F. · · 2022 · cited 245× · PMID 35740949 · DOI 10.3390/biom12060824
2. Metabolic dysfunction-associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment.
   Sangro P, de la Torre Aláez M, Sangro B, D'Avola D. · · 2023 · cited 91× · PMID 36976456 · DOI 10.1007/s13105-023-00954-4
3. PPAR-Targeted Therapies in the Treatment of Non-Alcoholic Fatty Liver Disease in Diabetic Patients.
   Lange NF, Graf V, Caussy C, Dufour JF. · · 2022 · cited 52× · PMID 35457120 · DOI 10.3390/ijms23084305
4. Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
   Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
5. Pharmacological Approaches to Nonalcoholic Fatty Liver Disease: Current and Future Therapies.
   Genua I, Cusi K. · · 2024 · cited 33× · PMID 38385098 · DOI 10.2337/dsi23-0012
6. Non-alcoholic Steatohepatitis Pathogenesis, Diagnosis, and Treatment.
   Zhu B, Chan SL, Li J, Li K, et al · · 2021 · cited 29× · PMID 34557535 · DOI 10.3389/fcvm.2021.742382
7. Lipid Disorders in NAFLD and Chronic Kidney Disease.
   Yang M, Geng CA, Liu X, Guan M. · · 2021 · cited 28× · PMID 34680522 · DOI 10.3390/biomedicines9101405
8. Understanding NAFLD: From Case Identification to Interventions, Outcomes, and Future Perspectives.
   Clayton-Chubb D, Kemp W, Majeed A, Lubel JS, et al · · 2023 · cited 26× · PMID 36771394 · DOI 10.3390/nu15030687