💬In plain words
What the trial is, and whether it could suit you
In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
* Liver transplant surgery within 8-24 weeks prior to randomization
* Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%)
* Ability to provide informed consent
* Discharged from the hospital following LT surgery
* Tolerating diet
* Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate)
* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study
Exclusion Criteria:
* BMI≤ 27kg/m2
* GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)
* History of gastroparesis
* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2
* History of pancreatitis
* History of active malignancy post- LT with the exception of non-melanoma skin cancers
* History of uncontrolled or unstable diabetic retinopathy or maculopathy
* Acute cellular rejection
* Hepatic artery thrombosis
* Medical non-compliance
* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
* History of hypersensitivity to semaglutide or its excipients
* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures
💊
What it tests
- Semaglutide Pen Injector
- Placebo
Virginia Commonwealth University
Richmond, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.