drugset / Trial / NCT05813249

Semaglutide in Nonalcoholic Fatty Liver Disease

NCT05813249

Phase 4 Completed 180 enrolled Zagazig University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The main question it aims to answer is: • Is the use of Semaglutide (oral or subcutaneous form) effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus? Participants will undergo: * Abdominal ultrasound. * Fibroscan with controlled attenuation parameter to assess liver stiffness (kPa) and liver steatosis (dB/m). * Fibrosis-4 score requires values of age, alanine aminotransferase, aspartate aminotransferase, and platelet count. * NAFLD Fibrosis Score requires values of age, BMI, platelet count, albumin, hyperglycemia, and ALT/AST ratio. Researchers will compare: * Group 1 will receive oral Semaglutide for 48 weeks. * Group 2 will receive injectable Semaglutide for 48 weeks. * Group 3 will receive Pioglitazone and/or Vitamin E. to see if there is an improvement in liver stiffness and severity of hepatic steatosis after 48 weeks.

Timeline

Start
2023-02-15
Primary completion
2024-02-15
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pioglitazone Small molecule
Comparator Semaglutide Peptide 2 mg Oral
Comparator Semaglutide Peptide 14 mg Oral
Comparator Vitamin E Other / unclassified

Indications