DRUG
Empagliflozin
Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
Status
Unknown
Phase
Phase 4
Enrollment
135
Locations
0
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
DRUG
Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
DRUG
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
Timeline
First posted
Dec 1, 2021
Study start
Dec 1, 2023
Primary completion
Jun 30, 2024
Study completion
Dec 31, 2025
Results posted
Not reported
Registry updated
Oct 4, 2022
Outcomes
Changes of HbA1c level
Time frame · baseline, week 12, week 24
Patients achieving the target level
Changes of CAP score
Time frame · baseline, week 24
Controlled Attenuation Parameter (CAP) score by transient elastography
Changes of LSM score
Time frame · baseline, week 24
Liver stiffness measurement (LSM) score by transient elastography
Changes of noninvasive liver fibrosis markers
Time frame · baseline, week 12, week 24
Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study
Changes of body weight and body composition
Time frame · baseline, week 24
Body composition by bioelectrical impedance will be measured at baseline and at the end of the study
Changes of lipid levels
Time frame · baseline, week 12, week 24
Cholesterol level will be measured at all visit days
Changes of ketone levels
Time frame · baseline, week 12, week 24
Ketone level will be measured at all visit days
Changes of liver parenchyma by ultrasonography
Time frame · baseline, week 24
improvement or deterioration
Changes of liver function parameters
Time frame · baseline, week 12, week 24
Liver enzymes, albumin will be measured at all visit days.
Changes of liver fibrosis biomarkers
Time frame · baseline, week 24
Type IV collagen
Changes of inflammation biomarker
Time frame · baseline, week 24
high-sensitivity CRP
Eligibility
Inclusion Criteria: 1. age 20 or over 2. uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea 3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m) 4. MAFLD: presence of any conditions 1. Overweight or obese: BMI ≥23 kg/m2 (Asian) 2. Metabolic dysregulation: at least of two of following criteria * Waist circumference: ≥90/80 cm in men and women (Asian) * Blood pressure ≥130/85 mmHg or drug treatment * Plasma triglycerides ≥150 mg/dL or drug treatment * Plasma HDL-cholesterol \<40/50 mg/dL for men and women or drug treatment * Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4% * HOMA-insulin resistance score ≥2.5 * Plasma high-sensitivity CRP \>2 mg/L Exclusion Criteria: 1. Significant alcohol consumption 2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes 3. Type 1 diabetes mellitus 4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs 5. Severe organ dysfunction 1. liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C 2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2 6. Hepatocellular carcinoma, active tumor, or metastasis 7. End-stage liver disease
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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