RECRUITING

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

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Conditions

NAFLDLiver Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-22
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05424003

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
  2. * Liver transplant surgery within 8-24 weeks prior to randomization
  3. * Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%)
  4. * Ability to provide informed consent
  5. * Discharged from the hospital following LT surgery
  6. * Tolerating diet
  7. * Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
  8. * Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate)
  9. * 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
  1. * BMI≤ 27kg/m2
  2. * GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
  3. * Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)
  4. * History of gastroparesis
  5. * Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2
  6. * History of pancreatitis
  7. * History of active malignancy post- LT with the exception of non-melanoma skin cancers
  8. * History of uncontrolled or unstable diabetic retinopathy or maculopathy
  9. * Acute cellular rejection
  10. * Hepatic artery thrombosis
  11. * Medical non-compliance
  12. * Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
  13. * History of hypersensitivity to semaglutide or its excipients
  14. * Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures

Contacts and Locations

Study Contact

Sherry Boyett, RN
CONTACT
804-828-5434
sherry.boyett@vcuhealth.org
Mohammad S Siddiqui, MD
CONTACT
mohammad.siddiqui@vcuhealth.org

Principal Investigator

Mohammad S Siddiqui, MD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Mohammad S Siddiqui, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-22
Study Completion Date2026-02

Study Record Updates

Study Start Date2024-02-22
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Liver Transplant

Additional Relevant MeSH Terms

  • NAFLD