Status:
RECRUITING
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
NAFLD
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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,...
Detailed Description
Weight gain following LT is common and a risk for cardiovascular disease and development of NAFLD. Developing NAFLD following LT can lead to patients developing scar tissue in the graft (transplanted ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05424003
Start Date
February 22 2024
End Date
February 1 2026
Last Update
July 3 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298