Status:
RECRUITING
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
Lead Sponsor:
Medanta, The Medicity, India
Conditions:
Liver Transplant; Complications
Diabete Mellitus
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
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 s...
Detailed Description
This trial is an investigator initiated, open label, case-control study to examine the effect of oral semaglutide (3mg for 4 weeks; then 7 mg for 20 weeks) once a day for 24 weeks on liver and pancrea...
Eligibility Criteria
Inclusion
- A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:
- On standard anti-diabetic agents (metformin and/or insulin) with an HbA1c of \<=9% at screening
- Body mass index of \>25 kg/m2
- Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.
- Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.
Exclusion
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score \>=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.
- Thyroid stimulating hormone (TSH) value that is either \< 0.45 mIU/L or \>10 mIU/L at Screening.
- Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.
- Use of a PPAR-γ agonist \[e.g., a thiazolidinedione (pioglitazone\], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks before the enrollment.
- Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.
- Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.
- Use of vitamin E within 4 weeks before screening.
- History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).
- History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
- Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.
- Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.
- Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.
- History of human immunodeficiency virus (HIV) antibody positive at Screening.
- Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).
- Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.
- History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.
- Patients with history of myopathies or evidence of active muscle disease.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06060392
Start Date
October 30 2023
End Date
November 1 2025
Last Update
June 13 2025
Active Locations (1)
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1
Division Of Endocrinology & Diabetes, Medanta The Medicity
Gurgaon, Haryana, India, 122001