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Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD)

Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD) - Ezetimibe therapy for Non-alcoholic fatty liver disease (NAFLD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001071
Enrollment
60
Registered
2011-06-30
Start date
2008-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease

Interventions

The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects were randomly assigned to receive one of the regimens
in Group A, the patients will receive Ezetimibe at a dose of 10mg per day for 6 months. The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects
in Group B, the patients will receive no drug for 6 months.

Sponsors

Osaka City University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. absence of clinically significant alcohol consumption (20g/day) 2. no other identifiable causes of liver diseases (infection with hepatitis B virus, hepatitis C virus, autoimmune liver diseases, and so on) 3. diagnosed as fatty liver by abdominal ultrasonography or CT 4. 180>LDL-C>140mg/dL

Exclusion criteria

Exclusion criteria: 1. past history of hypersensitivity to Ezetimibe 2. clinical sighs of severe liver injury such as acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis in Child B or C, hepatocellular carcinoma, and jaundice in combination with Statin. 3. women who are or possibly pregnant 4. past history of atherosclerotic disease(myocardial infarction , angina pectoris, cerebral stroke, and so on). 5. secondry hyperlipidemia or drug induced hyperlipidemia

Design outcomes

Primary

MeasureTime frame
changes of AST, ALT, Total cholesterol, and LDL-cholesterol at month 6 after the start of therapy

Countries

Japan

Contacts

Public ContactHideki Fujii

Osaka City University Graduate School of Medicine Department of Hepatology

rolahideki@med.osaka-cu.ac.jp06-6645-3811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026