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Clinical Trial Details

Trial ID: L2586
Source ID: NCT06060392
Associated Drug: Semaglutide Pill
Title: Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
Acronym: Sema-Lit
Status: RECRUITING
Study Results: NO
Results:
Conditions: Liver Transplant; Complications|Diabete Mellitus
Interventions: DRUG: Semaglutide Pill
Outcome Measures: Primary: Change in liver fat content, Quantified by MRI-PDFF, Baseline to 24 weeks | Secondary: Change in pancreatic fat content, Measured by DEXA, Baseline to 24 weeks|Change in body weight, Measured by DEXA, Baseline to 24 weeks|Change in body mass index, Measured by DEXA, Baseline to 24 weeks|Change in total fat percentage, Measured by DEXA, Baseline to 24 weeks|Change in lean muscle mass, Measured by DEXA, Baseline to 24 weeks|Change in bone mineral content, Measured by DEXA, Baseline to 24 weeks|Change in controlled attenuation parameter, Measured by transient elastography, Baseline to 24 weeks|Change in liver stiffness measurement, Measured by transient elastography, Baseline to 24 weeks|Change in aspartate aminotransferase, Baseline to 24 weeks|Change in alanine aminotransferase, Baseline to 24 weeks|Change in gamma-glutamyl transpeptidase, Baseline to 24 weeks|Change in serum creatinine concentrations, Baseline to 24 weeks|Change in HbA1c, Baseline to 24 weeks|Change in triglycerides, Baseline to 24 weeks|Change in HDL cholesterol, Baseline to 24 weeks|Change in LDL-cholesterol, Baseline to 24 weeks
Sponsor/Collaborators: Sponsor: Medanta, The Medicity, India
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-30
Completion Date: 2025-03-01
Results First Posted:
Last Update Posted: 2024-12-27
Locations: Division Of Endocrinology & Diabetes, Medanta The Medicity, Gurgaon, Haryana, 122001, India
URL: https://clinicaltrials.gov/show/NCT06060392