Randomized controlled trial of pemafibrate and fenofibrate for NAFLD with hypertriglyceridemia

Phase 2

Recruiting

• Conditions: AFLD with hypertriglyceridemia; NAFLD

• Registration Number: JPRN-jRCTs031200280
• Lead Sponsor: Iwaki Michihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-28
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Outpatients whose ages are between 20 and 80 years old at the time of obtaining consent.
2.Patients with fatty liver diagnosed by histological examination within 1 year prior to obtaining consent, or by imaging examination within 6 months prior to obtaining consent, and who have not responded to exercise or diet therapy for more than 3 months
3. Patients with hypertriglyceridemia (150-500 mg / dl) within 91 days before obtaining consent.
4. Patients with high ALT (male 43-100 IU / L, female 24-100 IU / L) within 91 days before obtaining consent.
5.Patients whose daily drinking amount is less than 30 g per day for men and less than 20 g for women in terms of ethanol at the time of obtaining consent
6.Patients who do not have other liver diseases such as hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, and primary biliary cholangitis at the time of consent acquisition
7. Patients with written informed consent.

Exclusion Criteria

1. Taking cyclosporine, rifampicin, amiodarone, and breast cancer treatments (tamoxifen, toremifene, raloxifene).
2. Patients with BMI <18.5kg/m2 at the time of consent.
3. Patients diagnosed with cirrhosis at the time of consent.
4. Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
5. Patients with T-Bil > normal upper limit x2 within 91 days before obtaining consent excluding Girbert syndrome.
6. Platelet count < 80,000 / uL within 91 days before obtaining consent.
7. Serum Cr level is 1.5 mg / dL or higher within 91 days before obtaining consent.
8. Patients with gallstones or biliary atresia at the time of consent.
9. Patients with severe infections, patients before and after surgery, patients with serious trauma at the time of consent,
10. Patients using fibrates within 91 days before obtaining consent.
11. Patients with a weight change of 10 % 91 days before obtaining consent.
12. Patients who have undergone or are planning bariatric surgery during the study period.
13. Patients with a history of type I diabetes.
14. Patients with HbA1c > 9.5 % within 91 days prior to obtaining consent.
15. Patients with psychosis, alcoholism, drug addiction, or drug addiction that may affect compliance with the research plan.
16. Patients who participated in other clinical trials 100 days before obtaining consent.
17. Pregnant women or patients who may be pregnant.
18. Patients with malignant tumor.
However, patients who have undergone radical surgery or who have completed administration of anticancer drugs are allowed to be registered, and patients who are being observed and evaluated for malignant tumors are excluded.
19. Patients who are considered inappropriate to participate in this study by the reseacher.
20. Patients who have received concomitant medications for more than 1 week.

Study & Design

• Study Type: Interventional
• Study Design: Not specified