Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: liver
- Who it enrolls
- age 18 Years to 75 Years; excludes diabetes; no BMI minimum stated; conditions: NAFLD
- Interventions
- Semaglutide Pen Injector; Placebo
- Conditions
- NAFLD
- Phase and size
- Phase 2 · 50 participants
- Dates
- Start 2024-02-22
Primary completion 2026-08-01 - Sponsor
- University of Virginia (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in weightBaseline to week 72
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.