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RECRUITING
NCT06989723
PHASE4

Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

Sponsor: Seoul National University Bundang Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-01-01

Completion Date

2027-06-30

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea