DelfaGLP-1 Atlas

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Enrolling by invitationPhase 4

Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease

Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

36

estimated

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criteria

•BMI 25-35•HbA1c ≥9%

Primary endpoint

•Liver fat content, change

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 IDNCT07274644
Org study ID2024-325-03

Timeline

Milestones

Study start2025-03-29actual
Study first posted2025-12-10actual
Last update posted2025-12-10actual
Primary completion2026-05-30estimated
Study completion2026-06-30estimated

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Diagnosis of Type 2 Diabetes Mellitus.

2. Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%.

3. HbA1c ≥ 9.0% at screening.

4. Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change < 10% in the past 3 months).

5. Stable antidiabetic regimen for at least 3 months prior to screening.

Exclusion criteria

•1. History of excessive alcohol consumption (≥210 g/week for men, ≥140 g/week for women).

2. Other known causes of chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis).

3. Use of medications known to affect liver fat content (e.g., thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, systemic corticosteroids) within 3 months prior to screening.

4. Presence of acute infections or diabetic acute complications (e.g., ketoacidosis, hyperosmolar state) within 2 weeks prior to screening.

5. History of pancreatitis or elevated amylase/lipase > 3 times the upper limit of normal (ULN).

6. Significant liver impairment (ALT or AST > 3 × ULN). 7. Moderate to severe renal impairment (eGFR < 60 mL/min/1.73m²). 8. Congestive heart failure (NYHA class III-IV). 9. Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN-2).

10. Severe gastrointestinal disease. 11. Contraindications to MRI examination. 12. Pregnancy or lactation. 13. Participation in another investigational drug study within 6 months prior to enrollment.

14. Known hypersensitivity to the study drugs or their excipients.

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
5
Weight & body composition
3
Glycemic / diabetes
3
Safety / tolerability / PK
2
Cardiometabolic biomarkers
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Changes of body weight

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Changes of body fat

Time frame:Baseline, 12 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Changes of muscle mass

Time frame:Baseline, 12 weeks

Lean mass

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Changes of HbA1c

Time frame:Baseline, 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes of plasma glucose

Time frame:Baseline, 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes of C-peptide

Time frame:Baseline, 12 weeks

C-peptide AUC

change from baseline, improvement

MASH / liver

5 endpoints
Primary/protocol endpoint

Changes of liver fat content

Time frame:Baseline, 12 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Changes of liver transaminase

Time frame:Baseline, 12 weeks

change from baseline, improvement

componentsALT, change, AST, change, γ-GT, change

Secondary/protocol endpoint/low confidence

Changes of liver inflammation index

Time frame:Baseline, 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes of liver stiffness measurement

Time frame:Baseline, 12 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Changes of FIB-4 index

Time frame:Baseline, 12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes of lipid metabolism indexes

Time frame:Baseline, 12 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Incidence of Hypoglycemic Events

Time frame:From Baseline to Week 12

threshold achievement, event

Other/protocol endpoint

Incidence of other adverse events

Time frame:From Baseline to Week 12

Treatment-emergent AEs (any)

event count, event

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.