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Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

RecruitingPhase 2Ages 18 Years - 75 YearsAllUniversity of Virginia
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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
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What it tests

  • Semaglutide Pen Injector
  • Placebo
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Where

1 site
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.
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