Using semaglutide to prevent weight gain after liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares semaglutide, a medication approved for obesity and Type 2 Diabetes, to a placebo to assess its effectiveness in preventing weight gain after liver transplantation. Researchers will evaluate the safety and tolerability of semaglutide, as well as its potential to prevent the development of Non-Alcoholic Fatty Liver Disease (NAFLD) using MRI and laboratory tests. Given the high risk of weight gain and subsequent health complications following liver transplant, this study aims to address a significant unmet need in post-transplant care. Participants will be monitored for weight changes and liver function to determine the medication's impact.

Why it matters

Who can join: the full rules

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

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Mohammad S Siddiqui, MD — Virginia Commonwealth University
• Study coordinator: Sherry Boyett, RN
• Email: sherry.boyett@vcuhealth.org
• Phone: 804-828-5434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.