Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT06060392
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2023-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
Sponsor:
Medanta, The Medicity, India
Organization:
Study Overview
Official Title:
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sema-Lit
Brief Summary:
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.
It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.
There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.
There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
Detailed Description:
This trial is an investigator initiated, open label, case-control study to examine the effect of oral semaglutide (3mg for 4 weeks; then 7 mg for 20 weeks) once a day for 24 weeks on liver and pancreatic fat content and body composition. Age- and BMI-matched controls will be recruited, who will receive standard care, except for oral semaglutide. Hepatic and pancreatic steatosis will be measured by MRI-proton-density fat fraction (PDFF), a validated quantitative biomarker for liver fat. Body composition parameters will be quantified by DEXA, the gold standard for body composition analysis. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine and hepatology out-patient clinic, who would primarily visit for management of post-liver transplantation care and diabetes mellitus. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial
Study visits
After careful assessment at the baseline visit, participants meeting all inclusion and exclusion criteria will receive oral semaglutide 3 mg once daily empty stomach for 4 weeks, then 7 mg for 20 weeks. Age- and BMI-matched controls will receive standard of care, except for oral semaglutide. Participants will be advised to return to the out-patient endocrine and hepatology/liver transplant clinics for follow-up visits at weeks 12 and 24.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Sample size calculation We assumed that a 5.0% change in absolute liver fat content between baseline and 24 weeks would be the minimally appreciable and clinically relevant difference. We will recruit 30 patients on a pilot study basis. We will also recruit 20 age- and BMI-matched controls.
Patient confidentiality Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
Study visits
After careful assessment at the baseline visit, participants meeting all inclusion and exclusion criteria will receive oral semaglutide 3 mg once daily empty stomach for 4 weeks, then 7 mg for 20 weeks. Age- and BMI-matched controls will receive standard of care, except for oral semaglutide. Participants will be advised to return to the out-patient endocrine and hepatology/liver transplant clinics for follow-up visits at weeks 12 and 24.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Sample size calculation We assumed that a 5.0% change in absolute liver fat content between baseline and 24 weeks would be the minimally appreciable and clinically relevant difference. We will recruit 30 patients on a pilot study basis. We will also recruit 20 age- and BMI-matched controls.
Patient confidentiality Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: