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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05140694
Other study ID # MAFLD_empa_dula
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2025

Study information

Verified date October 2022
Source Seoul National University Bundang Hospital
Contact Soo Lim, MD, PhD
Phone +82-31-787-7035
Email limsoo@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 135
Est. completion date December 31, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
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 Design


Intervention

Drug:
Empagliflozin
Empagliflozin 10 mg p.o. once daily (available to control over ~25mg)
Dulaglutide
Dulaglutide 0.75mg s.c. once a week (available to control over ~1.5mg)
Empagliflozin and Dulaglutide
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Changes of urine markers Urinalysis will be performed at all visit days baseline, week 12, week 24
Other Changes of bone health parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days baseline, week 12, week 24
Other Changes of gut microbiota gut microbiota composition, microbiota related to metabolic dysfunction baseline, week 24
Primary Changes of HbA1c level Patients achieving the target level baseline, week 12, week 24
Primary Changes of CAP score Controlled Attenuation Parameter (CAP) score by transient elastography baseline, week 24
Secondary Changes of LSM score Liver stiffness measurement (LSM) score by transient elastography baseline, week 24
Secondary Changes of noninvasive liver fibrosis markers Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study baseline, week 12, week 24
Secondary Changes of body weight and body composition Body composition by bioelectrical impedance will be measured at baseline and at the end of the study baseline, week 24
Secondary Changes of lipid levels Cholesterol level will be measured at all visit days baseline, week 12, week 24
Secondary Changes of ketone levels Ketone level will be measured at all visit days baseline, week 12, week 24
Secondary Changes of liver parenchyma by ultrasonography improvement or deterioration baseline, week 24
Secondary Changes of liver function parameters Liver enzymes, albumin will be measured at all visit days. baseline, week 12, week 24
Secondary Changes of liver fibrosis biomarkers Type IV collagen baseline, week 24
Secondary Changes of inflammation biomarker high-sensitivity CRP baseline, week 24
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