Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT07274644
Active, not recruiting Phase 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

NCT07274644 · tracked via the Priya Life Science China tracker
Sponsor
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)

iGlarLixi →IGlar 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)

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

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia Starting soon
FAD Subtype-Guided Combination Therapy for Unresectable Hepatocellular Carcinoma Starting soon
The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment Recruiting
Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis Recruiting
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings Recruiting

Other trials for the same condition

Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease (Version 3.0) Recruiting
Mobile Health and Wearable Devices for Diabetes Complication Management Recruiting
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial Recruiting
Efficacy and Safety of Rifaximin-α in Treating MASLD Recruiting
Effects of Different Exercises on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease Enrolling by invitation
Official registry record

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.

View NCT07274644 on ClinicalTrials.gov ↗ ← All trials in China