DelfaGLP-1 Atlas

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UnknownPhase 4

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

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

135

estimated

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criterion

•BMI ≥23

Primary endpoints

•HbA1c, change•Changes of CAP score

Identifiers

Registered as

NCT IDNCT05140694
Org study IDMAFLD_empa_dula

Timeline

Milestones

Study first posted2021-12-01actual
Last update posted2022-10-04actual
Study start2023-12-01estimated
Primary completion2024-06-30estimated
Study completion2025-12-31estimated

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
6
Cardiometabolic biomarkers
2
Other (unclassified)
2
Weight & body composition
1
Glycemic / diabetes
1
Renal / kidney
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Changes of body weight and body composition

Time frame:baseline, week 24

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Changes of HbA1c level

Time frame:baseline, week 12, week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

6 endpoints
Primary/protocol endpoint

Changes of CAP score

Time frame:baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint

Changes of LSM score

Time frame:baseline, week 24

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes of noninvasive liver fibrosis markers

Time frame:baseline, week 12, week 24

change from baseline, improvement

Secondary/protocol endpoint

Changes of liver parenchyma by ultrasonography

Time frame:baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint

Changes of liver function parameters

Time frame:baseline, week 12, week 24

change from baseline, improvement

Secondary/protocol endpoint

Changes of liver fibrosis biomarkers

Time frame:baseline, week 24

change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint/low confidence

Changes of urine markers

Time frame:baseline, week 12, week 24

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Changes of lipid levels

Time frame:baseline, week 12, week 24

change from baseline, improvement

Secondary/protocol endpoint

Changes of inflammation biomarker

Time frame:baseline, week 24

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Changes of bone health

Time frame:baseline, week 12, week 24

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Changes of ketone levels

Time frame:baseline, week 12, week 24

change from baseline, descriptive

Other/protocol endpoint/low confidence

Changes of gut microbiota

Time frame:baseline, week 24

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.