Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase
Phase 4
Started
2025-03-29
Last updated
2026-06-22
Condition(s) studied
Metabolic Dysfunction-Associated Steatotic Liver DiseaseDiabetes Mellitus Type 2
Investigational drug(s) / intervention(s)
iGlarLixiIGlar U100
iGlarLixi: The iGlarLixi is administered as a subcutaneous injection once daily within 1 hour before breakfast. The starting dose ranges from 0.1 to 0.2 U/kg, with a maximum daily dose of 20 U (equivalent to 20 U iGlar or 20 μg Lixi). Dose titration is guided by fasting self-monitored plasma glucose (SMPG) levels, with the goal of achieving a target range of 4.4-5.6 mmol/L while avoiding hypoglycemia. All participants continue to receive background metformin therapy throughout the treatment period.
IGlar U100: The iGlar is administered via subcutaneous injection once daily at a fixed time. The recommended starting dose ranges from 0.1 to 0.2 U/kg. The dose is subsequently titrated to achieve a fasting self-monitored plasma glucose (SMPG) target of 4.4-5.6 mmol/L, with careful attention to avoiding hypoglycemia. Throughout the study, all participants maintain their background metformin therapy
Study summary
This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Absolute change from baseline to Week 12 in hepatic fat fraction — Baseline, Week 12 The absolute change of liver fat content were measured by MRI-PDFF
Trial sites (1)
Facility
City
Region
Status
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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