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New treatment option for NAFLD
Official title Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
ClinicalTrials.gov ID: NCT05424003
What this study is testing
What is Semaglutide Pen Injector?
Semaglutide Pen Injector is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for nafld.
Also referred to as Wegovy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.