Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
ConditionNAFLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semaglutide Pen Injector
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Virginia
Lead sponsor
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov