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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called semaglutide can help prevent weight gain and the development of Non-Alcoholic Fatty Liver Disease (NAFLD) in people who have recently undergone liver transplantation. Participants will be randomly assigned to receive either semaglutide or a placebo (which is an inactive substance that looks like the real medication) to see how well it works. Researchers will also use MRI scans and lab tests to monitor the health of the liver after the transplant.

To be eligible for this study, participants should be between 18 and 75 years old and must have had a liver transplant within the last 8 to 24 weeks. They should also have certain blood sugar levels indicating diabetes or pre-diabetes, and they need to be recovering well from their surgery. Women who want to participate must not be pregnant or breastfeeding and should use reliable birth control during the study. If you decide to join, you’ll be closely monitored by medical professionals, and you'll play an important role in helping researchers understand how semaglutide can improve health outcomes after liver transplant.

Gender

ALL

Eligibility criteria

• 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