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

Description

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.

Conditions

NAFLD

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Study Overview

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Study Details

Study overview

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.

A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation

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

Condition
NAFLD
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Mohammad S Siddiqui, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2026-02