Fatty Liver, NonalcoholicPhase 1/2NCT04761848
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease
A Phase 1/2 study testing Cilostazol 50 MG in people with Fatty Liver, Nonalcoholic, run by Sadat City University at 1 site in Egypt.
Trial summary
The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- What is being tested?
- Cilostazol 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2021to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Adults between 18 and 60 years of age, both men and women,
- Clinical diagnosis of NAFLD, confirmed by imaging exams,
- Patients who present levels above the reference values of ALT, AST and ferritin.
Who cannot join
- Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
- Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
- Patients with schistosomiasis;
- Hemochromatosis
- Wilson's disease
- Viral or autoimmune hepatitis
Show all 14Show fewer
- HIV virus carriers
- Woman who is breastfeeding
- Users of illicit drugs
- Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
- Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
- Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
- Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease)
- Patients who do not participate in all stages of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.
The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD
- Conditions
- Fatty Liver, Nonalcoholic
- Being tested
- Cilostazol 50 MG, Placebo
- 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.
Cilostazol 50 MGDrug
Cilostazol 50 MG tablet twice daily
PlaceboDrug
Placebo tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | Not described Receives: Drug: Cilostazol 50 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic transaminases
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Measured: week 12
Serum ferritin
Serum ferritin
Measured: week 12
Secondary outcomes (5)
Lipid profile
Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention.
Measured: week 12
Glycated haemoglobin
Hb A1c (%)
Measured: week 12
Serum stem cell transforming factor beta
Serum stem cell transforming factor beta
Measured: 12 weeks
Adverse effects
Adverse effects
Measured: 12 weeks
FAM19A5 serum level
FAM19A5 serum level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start16 Feb 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Institutional and funding constrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761848
- Sponsor's protocol ID
- 10/2021IRI
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04761848
- Acronym / sponsor ID
- 10/2021IRI
- Conditions
- Fatty Liver, Nonalcoholic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional and funding constrains
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2021 (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.
The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: Cilostazol 50 MG |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults between 18 and 60 years of age, both men and women,
- Clinical diagnosis of NAFLD, confirmed by imaging exams,
- Patients who present levels above the reference values of ALT, AST and ferritin.
Key exclusion criteria (14 listed)
- Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
- Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
- Patients with schistosomiasis;
- Hemochromatosis
- Wilson's disease
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 |
|---|---|---|
| Cilostazol 50 MGCilostazol 50 MG tablet twice daily | Drug | Cilostazol |
| PlaceboPlacebo tablet twice daily | Drug | Placebo |
Primary outcome
Hepatic transaminases
Time frame: week 12
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Serum ferritin
Time frame: week 12
Serum ferritin
5 secondary outcomes
Lipid profile
Time frame: week 12
Glycated haemoglobin
Time frame: week 12
Serum stem cell transforming factor beta
Time frame: 12 weeks
Adverse effects
Time frame: 12 weeks
FAM19A5 serum level
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cilostazol 50 MG in people with Fatty Liver, Nonalcoholic, run by Sadat City 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 14 Jul 2025. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic transaminases (time frame: week 12). The study lists 2 primary outcomes in all. 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 14 Jul 2025.