NCT06989723

Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

Evaluation of Pioglitazone and Empagliflozin Combination Therapy in Type 2 Diabetes Patients With Metabolic Dysfunction-Associated Fatty Liver Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Although each agent has shown beneficial effects individually, evidence on their combined impact on liver health is scarce. This study seeks to determine whether the combination therapy yields additive improvements in hepatic steatosis, inflammation, and fibrosis, potentially offering a new therapeutic strategy for diabetic patients with fatty liver disease.

Conditions

• Type 2 Diabetes
• Fatty Liver

Interventions

Type	Name	Description
DRUG	Pioglitazone 15 MG [Actos]	Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food.
DRUG	Empagliflozin 10 MG [Jardiance]	Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food.
DRUG	Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]	Participants will receive one tablet of pioglitazone 15 mg and one tablet of empagliflozin 10 mg, administered orally once daily. Both tablets may be taken with or without food.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: South Korea