Actively Recruiting
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Led by Virginia Commonwealth University · Updated on 2025-07-03
50
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years who received liver transplant for any reason
- Liver transplant surgery occurred within 8 to 24 weeks before randomization
- Fasting glucose over 125 mg/dL or diagnosed diabetes (HbA1c 6.5% or use of diabetes medications) or pre-diabetes (HbA1c over 5.7%)
- Able to give informed consent
- Discharged from hospital after liver transplant surgery
- Able to tolerate diet
- Normal liver graft function as determined by treating hepatologist or surgeon
- Stable immunosuppression according to VCU post-transplant protocols (e.g., calcineurin inhibitors plus mycophenolate)
- Female participants must be non-pregnant (negative urine pregnancy test), non-lactating, surgically sterile or post-menopausal, or agree to use birth control during the study
You will not qualify if you...
- Body Mass Index (BMI) 27 kg/m2 or less
- Glomerular Filtration Rate (GFR) 25 ml/min/1.73m2 or less
- Type 1 autoimmune diabetes (diagnosed by anti-GAD or history of ketoacidosis)
- History of gastroparesis
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- History of pancreatitis
- Active malignancy after liver transplant except non-melanoma skin cancers
- Uncontrolled or unstable diabetic retinopathy or maculopathy
- Acute cellular rejection
- Hepatic artery thrombosis
- History of medical non-compliance
- Currently treated with GLP-1 receptor agonists or SGLT-2 inhibitors at screening
- Known allergy or hypersensitivity to semaglutide or its ingredients
- Women who are nursing, pregnant, planning pregnancy, or not using adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
S
Sherry Boyett, RN
CONTACT
M
Mohammad S Siddiqui, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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