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New treatment option for Liver Transplant; Complications
Official title Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
ClinicalTrials.gov ID: NCT06060392
What this study is testing
What is Semaglutide Pill?
Semaglutide Pill is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for liver transplant; complications.
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
- Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:
- On standard anti-diabetic agents (metformin and/or insulin) with an HbA1c of \<=9% at screening
- Body mass index of \>25 kg/m2
- people must be medically stable based on medical history, physical examination, and laboratory investigations.
- people must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
You likely can't join if
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the...
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years...
- Thyroid stimulating hormone (TSH) value that is either \ 10 mIU/L at Screening. Note: people on thyroid hormone replacement therapy must be on a...
- Use of a PPAR-γ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1...
- Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease...
See the full eligibility criteria
- A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:
- On standard anti-diabetic agents (metformin and/or insulin) with an HbA1c of \<=9% at screening
- Body mass index of \>25 kg/m2
- people must be medically stable based on medical history, physical examination, and laboratory investigations.
- people must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT)...
- Thyroid stimulating hormone (TSH) value that is either \ 10 mIU/L at Screening. Note: people on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.
- Use of a PPAR-γ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks...
- Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not...
- Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization...
- Use of vitamin E within 4 weeks before screening.
- History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).
- History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important...
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1 73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
- people with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.
- Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.
- Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.
- History of human immunodeficiency virus (HIV) antibody positive at Screening.
- Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).
- Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.
- History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.
- Patients with history of myopathies or evidence of active muscle disease.
The study team makes the final eligibility decision.
Where it's taking place
- Gurgaon, Haryana, India
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, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gurgaon, Haryana, India. 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.