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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
University of Virginia
Study ID
NCT05424003
Phase
PHASE2
Status
Recruiting
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Conditions

  • NAFLD

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen Injector — DRUG
    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 — DRUG
    Placebo solution injected weekly for 72 weeks

Study Details

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.

Key Dates

Start date
Feb 22, 2024
Status verified
Jun 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

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By research site
Virginia Commonwealth University· Richmond, VA

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