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Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

NCT06989723 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Celltrion

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989723 on ClinicalTrials.gov