Last reviewed · How we verify
NCT05140694
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
Phase 4 trial testing Empagliflozin in Metabolic-associated Fatty Liver Disease in 135 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Seoul National University Bundang Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 1 December 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Empagliflozin (empagliflozin) — full drug profile →
- Dulaglutide (DULAGLUTIDE) — full drug profile →
- Empagliflozin and Dulaglutide — full drug profile →
Conditions studied
- Metabolic-associated Fatty Liver Disease — all drugs for Metabolic-associated Fatty Liver Disease →
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Seoul National University Bundang Hospital
Who can join
Adults 20 to 90, any sex, with Metabolic-associated Fatty Liver Disease or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Glucagon-like Peptide 1, Glucose-Dependent Insulinotropic Polypeptide, and Glucagon Receptor Agonists in Metabolic Dysfunction-Associated Steatotic Liver Disease: Novel Medication in New Liver Disease Nomenclature.
Chrysavgis LG, Kazanas S, Bafa K, Rozani S, et al · · 2024 · cited 12× · PMID 38612640 · DOI 10.3390/ijms25073832 -
Role of incretins and glucagon receptor agonists in metabolic dysfunction-associated steatotic liver disease: Opportunities and challenges.
Xie C, Alkhouri N, Elfeki MA. · · 2024 · cited 9× · PMID 38818288 · DOI 10.4254/wjh.v16.i5.731 -
Pharmaceutical Strategies to Improve Druggability of Potential Drug Candidates in Nonalcoholic Fatty Liver Disease Therapy.
Amatya R, Lee D, Min KA, Shin MC. · · 2023 · cited 9× · PMID 37514148 · DOI 10.3390/pharmaceutics15071963 -
Pharmacotherapy for Non-alcoholic Fatty Liver Disease Associated with Diabetes Mellitus Type 2.
Koullias ES, Koskinas J. · · 2022 · cited 4× · PMID 36304499 · DOI 10.14218/jcth.2021.00564 -
Hepatic Mechanisms of Myocardial Infarction: A New Perspective in Metabolic Dysfunction-Associated Fatty Liver Disease.
Cui J, Wang W, Xu Q, Zhu M, et al · · 2025 · PMID 40879000 · DOI 10.1161/jaha.124.040775
Verify or expand the search:
- PubMed search for NCT05140694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empagliflozin
Trials testing the same drug.
- NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD · Phase 2 · not yet recruiting
- NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting
Other recruiting trials for Metabolic-associated Fatty Liver Disease
Currently open trials in the same condition.
- NCT07149571 — To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status · recruiting
- NCT07185932 — Efficacy and Safety of Rifaximin in Treating MAFLD · EARLY_PHASE1 · recruiting
Other Seoul National University Bundang Hospital trials
Trials by the same sponsor.
- NCT07459725 — Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke · NA · not yet recruiting
- NCT07455279 — Surface Electromyographic Analysis of Normal Swallowing in Children: An Exploratory Study · not yet recruiting
- NCT07477574 — Muscle-Specific Multimodal AI for Sarcopenia Diagnosis · NA · not yet recruiting
- NCT07505290 — Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial f · NA · active not recruiting
- NCT07305662 — Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGU · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05140694 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul National University Bundang Hospital
- Last refreshed: 4 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05140694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing