Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Recruiting · NCT05424003 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSemaglutide Pen Injector
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Virginia Commonwealth University - Richmond, Virginia, United States