drugset / Trial / NCT07274644
Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease
Phase 4
Active not recruiting
36 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-29
- Primary completion
- 2026-06-30
- Completion
- 2026-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iGlarLixi | Unknown | 0.1 iu/kg | Subcutaneous |
| Subject | iGlarLixi | Unknown | 0.2 iu/kg | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 0.1 iu/kg | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |