NCT05424003RecruitingPhase 2
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Jun 2022
- Start date
- 22 Feb 2024
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- University of Virginia
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05424003
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 22 Feb 2024 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Hepatic artery thrombosis
- History of hypersensitivity to semaglutide or its excipients
Lab values
- GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
- Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
Other
- BMI≤ 27kg/m2
- Acute cellular rejection
- Medical non-compliance
- Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.