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

NCT ID: NCT07274644

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-29
• Study Completion Date: 2026-06-30

Brief 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.

Detailed Description

This study is designed as a single-center, randomized, open-label, parallel controlled trial. A total of 36 participants with T2DM and MASLD (defined by MRI-PDFF ≥10%) will be randomized in a 1:1 ratio to receive either once-daily iGlarLixi or iGlar, both in combination with metformin, for 12 weeks. The primary outcome is the change in liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to week 12. Key secondary outcomes include changes in liver enzymes, liver inflammation, fibrosis indices (assessed by transient elastography and FIB-4 index), body composition (weight, BMI, waist circumference, waist-to-hip ratio, and visceral fat area), glycemic control (HbA1c, fasting and postprandial glucose), insulin function, lipid profiles, and uric acid. Safety assessments will include monitoring of hypoglycemic events, gastrointestinal adverse events, and other adverse events.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iGlarLixi group

Participants receive iGlarLixi once daily before breakfast for 12 weeks.

Group Type: EXPERIMENTAL

iGlarLixi

Intervention Type: DRUG

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 group

Participants receive iGlar once daily at a fixed time for 12 weeks.

Group Type: OTHER

IGlar U100

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Yan Bi

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Bi

Role: STUDY_DIRECTOR

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

Locations

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2024-325-03

Identifier Type: -

Identifier Source: org_study_id