Testing roflumilast for people with nonalcoholic fatty liver disease
Tests roflumilast against a placebo in adults with nonalcoholic fatty liver disease.
Plain-language title generated from the registry record
Registry title: Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
Key facts
- Where
- Tanta, EgyptSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07900087, who can take part
Where in Egypt
- Faculty of Medicine, Tanta University, Tanta, EgyptTanta, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanta University
- Trial code
- NCT07900087
- Record updated
- 28 October 2026
- Original description
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%.Read full original descriptionShow less
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
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%.
Inclusion: Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).
Exclusion: Pregnant and/or lactating women Excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women) Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, and autoimmune hepatitis; Patients suffering from chronic kidney disease, and hyper/hypoparathyroidism Hypersensitivity to roflumilast.