Study of Oral Semaglutide Effects on Liver Fat and Body Composition in Adults with Diabetes After Liver Transplant

What this Trial Is About

Nonalcoholic fatty liver disease NAFLD includes a range of liver problems from fat buildup to severe scarring and cirrhosis. It is closely linked to insulin resistance and conditions like obesity, type 2 diabetes, metabolic syndrome, and abnormal cholesterol levels. Some people who have had a liver transplant develop NAFLD in their new liver, partly due to ongoing risk factors such as reduced physical activity and the use of steroids and immunosuppressants after transplantation. Currently, no medication is approved specifically for preventing or treating NAFLD in this group. This study is an open-label case-control trial investigating the effects of oral semaglutide, a drug approved for diabetes and obesity, on liver fat, liver enzymes, and body composition in liver transplant recipients with diabetes. Participants will take semaglutide daily, starting with 3 mg for 4 weeks, then 7 mg for 20 weeks. A control group matched by age and body mass index will receive standard care without semaglutide. Liver and pancreatic fat will be measured using MRI-proton-density fat fraction PDFF, and body composition will be assessed by DEXA scans. Participants will be evaluated at the start and then at 12 and 24 weeks. The study will monitor changes in liver fat, pancreatic fat, body weight, body mass index, fat percentage, muscle mass, bone mineral content, liver stiffness, and various blood markers including liver enzymes and cholesterol. MRI scans will be analyzed by blinded radiologists to ensure accuracy. The total study duration for each participant is 24 weeks, with careful data protection and insurance coverage for any adverse effects during the trial.

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus