A Phase 2/3 interventional study of Placebo and Roflumilast in NAFLD (Nonalcoholic Fatty Liver Disease), sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment
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Among 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University — 6 open to participants now, 8 under way, 4 of them phase 3. Non-alcoholic Fatty Liver Disease · Tanta University.
Among the 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University, this one is the 3rd largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 2/3, and was the 12th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →6 of the 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University are open now, in 1 country. Recruiting first, the newest first:
Tanta University · Sites in Egypt
Ages 18–65
Tanta University · Sites in Egypt
Ages 18+ · Healthy volunteers
Tanta University · Sites in Egypt
Ages 18+ · Healthy volunteers
Tanta University · Sites in Egypt
Ages 18–60
Tanta University
Ages 18+
By country, each count listing its studies:
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 5 · Phase 4 2
First in 2019; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is close to the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 58 across the 12 interventional studies, 500 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Tanta University is the lead sponsor of 1,013 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
3 of the studies in Non-alcoholic Fatty Liver Disease by Tanta University that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07900100Phase 3Tanta UniversityEvaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients. | 2027-06-20 |
| NCT07900087Phase 3Tanta UniversityEvaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients | 2027-08-01 |
| NCT06863376Tanta UniversityEvaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients | 2027-03-20 |
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Among the 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University, from their registry updates:
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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%.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).
Exclusion Criteria:
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 hepatitis.
Patients suffering from chronic kidney disease, and hyper/hypoparathyroidism to roflumilast.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the standard conventional therapy in addition to placebo for 3 months.
Drug: Placebo
Patients were given the standard conventional therapy plus roflumilast (0.5 mg/day).
Drug: Roflumilast
Placeb tablets will have the same look and taste as the treatment drug
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
The change in the degree of steatosis in the Ultra Sound
The change in the degree of steatosis in the Ultra Sound
Time frame: 3 months
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Roflumilast
Non-alcoholic Fatty Liver Disease →