NAFLD (Nonalcoholic Fatty Liver Disease)Phase 2/3NCT07900087
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
A Phase 2/3 study testing Roflumilast in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 20 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta, Tanta, 34518
Mostafa Bahaa, PhD, 01025538337, mbahaa@horus.edu.eg
Mostafa Bahaa, PhD
About this study
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%.
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Being tested
- Placebo, Roflumilast
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placeb tablets will have the same look and taste as the treatment drug
RoflumilastDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive the standard conventional therapy in addition to placebo for 3 months. Receives: Drug: Placebo |
| Treatment arm | Active comparator | Patients were given the standard conventional therapy plus roflumilast (0.5 mg/day). Receives: Drug: Roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the degree of steatosis in the Ultra Sound
The change in the degree of steatosis in the Ultra Sound
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD (Nonalcoholic Fatty Liver Disease)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
- Investigators
- Mostafa Bahaa, Principal investigator, Faculty of Pharmacy, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900087
- Sponsor's protocol ID
- 84756R
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT07900087
- Acronym / sponsor ID
- 84756R
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: PlaceboPatients will receive the standard conventional therapy in addition to placebo for 3 months. |
| Treatment arm | Active comparator | Drug: RoflumilastPatients were given the standard conventional therapy plus roflumilast (0.5 mg/day). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlaceb tablets will have the same look and taste as the treatment drug | Drug | Control group |
| RoflumilastRoflumilast 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 | Drug | Treatment arm |
Primary outcome
The change in the degree of steatosis in the Ultra Sound
Time frame: 3 months
The change in the degree of steatosis in the Ultra Sound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Bahaa principal investigator
Faculty of Pharmacy, Horus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Roflumilast in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Bahaa, PhD (01025538337, mbahaa@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the degree of steatosis in the Ultra Sound (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.