Using semaglutide to prevent weight gain after liver transplant
A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation
This study is testing if the medication semaglutide can help people who have had a liver transplant avoid gaining weight and developing liver problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05424003 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have undergone liver transplantation within the last 8-24 weeks and have specific metabolic conditions such as diabetes or pre-diabetes.
Not a fit: Patients who are not within the specified age range, have not undergone liver transplantation, or have contraindications to semaglutide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to prevent weight gain and related complications in liver transplant recipients.
How similar studies have performed: While semaglutide has shown effectiveness in non-transplant populations for weight management and metabolic conditions, its use in liver transplant patients is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Richmond, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.