Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05424003
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05424003
Study Brief:
Protocol Section:
NCT05424003