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Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
Sponsor: Tanta University
Summary
Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption \>30 g for men and \>20 g for women. Alcohol consumption above these limits indicates alcoholic liver disease. In parallel with the obesity and metabolic syndrome epidemic, there has been a rise in NAFL and more advanced diseases. Currently, it is estimated that the prevalence of NAFLD worldwide is approximately 25%.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-11-01
Completion Date
2027-08-20
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placeb tablets will have the same look and taste as the treatment drug
Roflumilast
Roflumilast is the first drug targeting PDE4 that was marketed for treatment of chronic obstructive pulmonary disease (COPD) with relatively weak potency inducing nausea and vomiting
Locations (1)
Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta, Tanta, Egypt