Evaluation of the Effects of Liraglutide on Metabolic Parameters, Liver Function, and Non-Invasive Liver Fibrosis Indices in Patients with Type 2 Diabetes and Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial

To evaluate and compare the efficacy and tolerability of Liraglutide versus standard care on metabolic parameters (FBS, HbA1c, BMI), liver function tests (ALT, AST), and non-invasive liver fibrosis indices (FIB-4, LSM, CAP) in patients with Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Randomized, Open-label, Controlled, Parallel-group Clinical Trial.

The study will be conducted at Baqiyatallah hospital. After screening and informed consent, patients will be randomly assigned to two groups: Intervention (Liraglutide added to standard care) and Control. The intervention duration is 12 weeks. Data collection includes laboratory tests, FibroScan (CAP/LSM), and calculated indices (FIB-4).

Inclusion: Age 35-65 years. BMI between 27-40 kg/m². Confirmed diagnosis of Type 2 Diabetes. Stable antidiabetic regimen for at least 3 months. Confirmed hepatic steatosis (CAP ≥ 245 dB/m) via FibroScan. Exclusion: Significant alcohol consumption (>30g/day for men, >20g/day for women). History of acute pancreatitis. Pregnancy or lactation. Concomitant use of other GLP-1 receptor agonists. Need for changes in antidiabetic medication dosage in the past 12 weeks.

Intervention Group: Daily subcutaneous Liraglutide. Dose titration: 0.6 mg (Week 1), 1.2 mg (Week 2), and 1.8 mg (Week 3 onwards). Patients continue their previous antidiabetic medications at fixed doses (with prophylactic dose reduction of sulfonylureas/insulin if necessary). Control Group: Standard care (previous medications at fixed doses + lifestyle education).

Change in liver steatosis level (CAP index in FibroScan) from baseline to Week 12. Change in anthropometric indices (Weight and BMI) from baseline to Week 12.

Random assignment to intervention and control groups using permutation blocks of 4 (Block Size 4) and a ratio of 1:1. Random sequences were generated by a statistician using the online Sealed Envelope tool for two fibrosis classes (less than 8 and greater than or equal to 8 kPa). The independent investigator assigned and notified the group after receiving the patient code.

This study is open-label for both the patient and the physician, as the method of administering liraglutide (daily injection with dose titration) is different from the control group. However, the FibroScan machine operator and the biostatistician are completely blinded to the patients' treatment group to avoid bias in the assessment of the primary and secondary outcomes.

All data can be shared after un-identification of individuals.

Access period starts 6 months after the results are published

The data will be available to researchers working in academic centers as well as to industry professionals.

Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager.

For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Ali Abyazi Herris.

After receiving a written request from researchers... by the Baqiyatallah Research Center for Gastroenterology and Liver Disease and reviewing the application in the Research Council of the Research Center, the documents or data files will be delivered to the applicant after about 10 days.