Recruiting
Phase 2

Semaglutide

Sponsor:

University of Virginia

Code:

NCT05424003

Conditions

NAFLD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen Injector

Placebo

Study Details

Brief summary:

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

Study ID

NCT05424003

Start date

Feb 22, 2024

Status verified date

Jun, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Semaglutide administered subcutaneously (under the skin) once weekly. There will be a 20 week lead in period of dose escalation before reaching the target dose of 2.4mg weekly. Semaglutide will then be administered at the maximum tolerated dose for 52 weeks.

placebo comparator: Placebo

Placebo administered subcutaneously (under the skin) once weekly.

Interventions

Semaglutide Pen Injector

Starting dose of 0.24 mg injected weekly and increased every 4 weeks to a potential maximum dose of 2.4 mg weekly at 20 weeks followed by 52 weeks of weekly injections at the maximum tolerable dose

Placebo

Placebo solution injected weekly for 72 weeks

Primary outcome measure

  • Change in weight [ Time Frame: Baseline to week 72 ]

Central Contacts and Locations

Central contacts

Sherry Boyett, RN

804-828-5434sherry.boyett@vcuhealth.org

Mohammad S Siddiqui, MD

mohammad.siddiqui@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

University of Virginia

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Liver Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-04.