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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Sherry Boyett, RN
sherry.boyett@vcuhealth.org
804-828-5434
Backup
Mohammad S Siddiqui, MD
mohammad.siddiqui@vcuhealth.org
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2026-02
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Virginia Commonwealth University
Collaborators: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov