NCT05140694

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone. The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.

Conditions

• Metabolic-associated Fatty Liver Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin	Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
DRUG	Dulaglutide	Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
DRUG	Empagliflozin and Dulaglutide	Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-30
• Completion: 2025-12-31
• First posted: 2021-12-01
• Last updated: 2022-10-04