Cilostazol for nonalcoholic fatty liver disease.
Evaluating the Safety and Efficacy of Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
PHASE1; PHASE2 · Tanta University · NCT07238985
This trial will test whether the medicine cilostazol can reduce liver fat and improve liver health in adults with nonalcoholic fatty liver disease.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Damietta, New Damietta) |
| Trial ID | NCT07238985 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 1/2 study will give adults with ultrasound-diagnosed nonalcoholic fatty liver disease standard care, and some participants will also receive the drug cilostazol to test its effects on liver fat and function. Eligible participants are adults over 18 diagnosed by upper abdominal ultrasound, while people with significant alcohol use, other chronic liver diseases, pregnancy or lactation, congestive heart failure, chronic kidney disease, or parathyroid disorders are excluded. Study outcomes will include measures of liver fat and liver-related blood tests, with close safety monitoring for known cilostazol effects. The study is conducted at a single site operated by Tanta University (Mostafa Bahaa center) in New Damietta, Egypt.
Who should consider this trial
Good fit: Adults over 18 with fatty liver confirmed by upper abdominal ultrasound who do not have excess alcohol use, other chronic liver disease, pregnancy or breastfeeding, congestive heart failure, chronic kidney disease, or parathyroid disorders.
Not a fit: People with other identified causes of liver disease (viral, autoimmune, drug-induced), heavy alcohol use, pregnant or lactating women, or those with congestive heart failure or significant kidney disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, cilostazol could lower liver fat and improve liver enzyme measures, potentially slowing progression of NAFLD.
How similar studies have performed: Applying cilostazol to NAFLD is relatively novel: small preclinical and metabolic studies hint at possible benefit, but definitive clinical success in NAFLD has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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, autoimmune hepatitis. Patients suffering from chronic kidney disease, hyper/hypoparathyroidism, and congestive heart failure patients
Where this trial is running
Damietta, New Damietta
- Mostafa Bahaa — Damietta, New Damietta, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fatty Liver