Actively Recruiting
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
Led by Medanta, The Medicity, India · Updated on 2025-06-13
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia. It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time. There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
CONDITIONS
Official Title
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 30 years or older with liver transplantation at least 3 months ago
- On standard diabetes treatment with metformin and/or insulin and HbA1c of 9% or less at screening
- Body mass index over 25 kg/m2
- Medically stable based on history, physical exam, and lab tests
- Willing and able to follow study rules and restrictions
- Signed informed consent indicating understanding of the study and willingness to participate
You will not qualify if you...
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplant, or diabetes due to pancreatitis or pancreatectomy
- Unstable blood sugar control with widely varying glucose measurements
- History of drug or alcohol abuse within 3 years or significant alcohol use in past 5 years
- Thyroid stimulating hormone (TSH) outside 0.45 to 10 mIU/L unless stable on thyroid hormone therapy for at least 4 weeks
- Use of certain diabetes medications (PPAR-b3 agonists, SGLT2 inhibitors, GLP-1 receptor agonists) within 12 weeks before enrollment
- Ongoing eating disorder or significant weight change of 5% or more within 12 weeks before screening
- Recent heart attack, unstable angina, pulmonary hypertension, revascularization, or severe heart disease
- Use of vitamin E within 4 weeks before screening
- History of bariatric or major upper gastrointestinal surgery
- History of diabetic gastroparesis or significant gastrointestinal disorders
- Estimated kidney function below 45 mL/min/1.73 m2
- Presence of metallic material or other MRI contraindications
- Claustrophobia or anxiety preventing MRI participation
- Significant blood disorders
- Positive for HIV antibodies
- Contraindications to oral semaglutide use
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or psychiatric conditions
- History or evidence of muscle diseases or myopathies
AI-Screening
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Trial Site Locations
Total: 1 location
1
Division Of Endocrinology & Diabetes, Medanta The Medicity
Gurgaon, Haryana, India, 122001
Actively Recruiting
Research Team
M
Mr Surender, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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