Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-inducedcirrhosis, autoimmune hepatitis, etc.)

• Liver transplant surgery within 8-24 weeks prior to randomization

• 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 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 ≤ 25 ml/min/1.73m2

• Type 1 autoimmune diabetes (by anti-GAD or history of ketoacidosis)

• History of gastroparesis

• Familial or personal history of medullary thyroid cancer or MEN 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-1RA or SGLT-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 adequatecontraceptive measures