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

NCT07274644 | Enrolling By Invitation Phase 4

• 1 other identifier: 2024-325-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes of liver fat content

  The changes of liver fat content were measured by MRI-PDFF

  Baseline, 12 weeks

Secondary Outcomes (11)

• Changes of liver transaminase

  Baseline, 12 weeks

• Changes of liver inflammation index

  Baseline, 12 weeks

• Changes of liver stiffness measurement

  Baseline, 12 weeks

• Changes of FIB-4 index

  Baseline, 12 weeks

• Changes of body weight

  Baseline, 12 weeks

Other Outcomes (2)

• Incidence of Hypoglycemic Events

  From Baseline to Week 12

• Incidence of other adverse events

  From Baseline to Week 12

Study Arms (2)

iGlarLixi group

EXPERIMENTAL

Participants receive iGlarLixi once daily before breakfast for 12 weeks.

Drug: iGlarLixi

iGlar group

OTHER

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

Drug: IGlar U100

Interventions

iGlarLixi 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.

iGlarLixi group

IGlar U100 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

iGlar group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes Mellitus.
• Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%.
• HbA1c ≥ 9.0% at screening.
• Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change \< 10% in the past 3 months).
• Stable antidiabetic regimen for at least 3 months prior to screening.

You may not qualify if:

• \. History of excessive alcohol consumption (≥210 g/week for men, ≥140 g/week for women).
• \. Other known causes of chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis).
• \. 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.
• \. Presence of acute infections or diabetic acute complications (e.g., ketoacidosis, hyperosmolar state) within 2 weeks prior to screening.
• \. History of pancreatitis or elevated amylase/lipase \> 3 times the upper limit of normal (ULN).
• \. 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).
• \. 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.
• \. Known hypersensitivity to the study drugs or their excipients.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yan Bi

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 10, 2025
• Study Start: March 29, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)