DelfaGLP-1 Atlas

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NAMELS-18

Completed

Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

Effect of Dulaglutide vs Empagliflozin on Non-alcoholic Fatty Liver Disease of Patients With Type 2 Diabetes Mellitus

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

78

actual

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•MRI-PDFF, % change•>30% Liver Fat Fraction reduction

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05946148
Org study IDSC12/16-6-2016

Timeline

Milestones

Study start2018-06-01actual
Primary completion2021-05-31actual
Study completion2021-05-31actual
Study first posted2023-07-14actual
Last update posted2023-07-14actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Caucasian, 25-75 years old, diagnosed with type 2 diabetes mellitus and fatty liver.

Inclusion criteria

Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months

Exclusion criteria

Recent (last 5 years) medical history of cancer, pancreatitis, viral hepatitis or any other cause of liver disease (alcohol abuse, autoimmune hepatitis, hemochromatosis, heart failure etc.) Recent alteration (<6 months) of anti-diabetic regimen. Already established treatment with GLP1-ras or SGLT2-is prior to screening. Treatment with Pioglitazone. Corticotherapy administration. Pregnant or planning for pregnancy.

Endpoints (9)

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
7
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body Mass Index change

Time frame:52 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

HbA1c change

Time frame:52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

7 endpoints
Primary/protocol endpoint

Liver Fat Fraction reduction

Time frame:52 weeks

MRI-PDFF, % change

change from baseline, improvement

Primary/protocol endpoint

>30% Liver Fat Fraction reduction

Time frame:52 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Fatty Liver Index (FLI)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fibrosis-4 Index (FIB-4)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Aspartate Aminotransferase to Platelet ratio Index (APRI)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

NAFLD Fibrosis Score (NFS)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Shearwave Elastography (SWE)

Time frame:52 weeks

change from baseline, improvement

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.