NCT07274644Active, not recruitingPhase 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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 29 Mar 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Type 2 diabetes
- NCT number
- NCT07274644
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 36
- From 29 Mar 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.