Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: liver
- Who it enrolls
- age 20 Years to 90 Years; BMI ≥23 required; non-obese participants included; conditions: Metabolic-associated Fatty Liver Disease; Type 2 Diabetes
- Interventions
- Empagliflozin; Dulaglutide; Empagliflozin and Dulaglutide
- Conditions
- Metabolic-associated Fatty Liver Disease; Type 2 Diabetes
- Phase and size
- Phase 4 · 135 participants
- Dates
- Start 2023-12-01
Primary completion 2024-06-30 - Sponsor
- Seoul National University Bundang Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Changes of HbA1c levelbaseline, week 12, week 24
- Changes of CAP scorebaseline, week 24
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.