臨床研究等提出・公開システム

An exploratory, open-label, single-arm study to evaluate the effect of HYA administration on improving liver dysfunction in patients with nonalcoholic fatty liver disease(metabolic dysfunction-associated steatotic liver disease).

HYAT(HYA-Liver trial)

Hosooka Tetsuya

Yoshimi Clinic

3117-1, Mannoharashinden, Fujinomiya-shi, Shizuoka

thosooka@u-shizuoka-ken.ac.jp

Hosooka Tetsuya

University of Shizuoka

52-1, Yada, Suruga-ku, Shizuoka-shi, Shizuoka

+81-54-264-5763

thosooka@u-shizuoka-ken.ac.jp

Recruiting

Nov. 28, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Persons diagnosed with NAFLD (MASLD) (regardless of gender) who are between 20 and 70 years of age at the time consent is obtained.
2. patients with fatty liver on abdominal ultrasonography
3. patients with an ALT level of 35 U/L or higher
4. patients with ALT level >= 35 U/L and no decrease of >= 10% after at least 3 months of diet and exercise therapy
5. patients whose alcohol intake (net alcohol) is less than 30 g/day for men and 20 g/day for women
6. patients with negative HBs antigen and HCV antibody
7. patients who have given their free written consent to participate in this clinical study

1.Patients with liver disease of other etiologies than NAFLD (MASLD) such as drug-induced/viral/autoimmune hepatitis/primary biliary cirrhosis/primary sclerosing cholangitis/Wilson's disease
2. patients with severe hepatic dysfunction (AST or ALT > 5 times the upper limit of reference values), cirrhosis (platelet count < 150,000/ml), or hepatic failure (presence of ascites or jaundice, serum albumin < 3.5 g/dl, serum bilirubin > 2.0 mg/dl)
3. patients with severe renal dysfunction (eGFR less than 30)
4. patients with cancer or who have undergone any treatment for cancer within the past 5 years
5. patients with poor glycemic control (HbA1c > 8.5%)
6. patients with heart failure or a history of coronary artery disease (myocardial infarction, angina pectoris) or cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
7. patients who are pregnant or may be pregnant, and lactating patients
8. patients who have been taking oral or intravenous steroids for more than 1 month
9. patients who have newly started taking drugs (SGLT2 inhibitors, thiazolidinediones, GLP-1 receptor agonists, pemafibrate, vitamin E preparations) that may lead to improvement of fatty liver disease within 6 months prior to obtaining consent
10. patients who have lost 5% of their body weight within 3 months prior to obtaining consent
11. other patients deemed inappropriate by the investigator of this clinical study.

Both

nonalcoholic fatty liver disease(NAFLD)

Eight (2400 mg) soft capsules containing HYA (10-hydoroxy-cis-12-octadecenoic acid) per day, 4 capsules (1200 mg) each twice daily before breakfast (or lunch) and dinner with water or lukewarm water, taken without chewing. Duration of use is 16 weeks.

nonalcoholic fatty liver disease (NAFLD),metabolic dysfunction-associated steatotic liver disease (MASLD)

multicenter, open-label, single-arm study

D065626

ALT after 16 weeks of HYA administration

(Efficacy endpoints)
1. ALT at 4, 8, and 12 weeks after HYA administration
2. Liver function markers other than ALT at 4, 8, 12, and 16 weeks after HYA administration
3.Hepatic fibrosis markers after 16 weeks of HYA administration
4.Inflammation- and apoptosis-related markers after 16 weeks of HYA administration
5.FIB-4 index at 4, 8, 12, and 16 weeks after HYA administration
6.Glucose metabolism at 4, 8, 12, and 16 weeks after HYA administration
7.Lipid metabolism at 4, 8, 12, and 16 weeks after HYA administration
8.HOMA-IR and Adipo-IR after 16 weeks of HYA administration
9.Adipocytokines after 16 weeks of HYA administration
10. Body weight, abdominal circumference, and BMI at 4, 8, 12, and 16 weeks after HYA administration
11.Body composition at 4, 8, 12, and 16 weeks after HYA administration
12. Liver fat content (ultrasonic attenuation rate) after 16 weeks of HYA administration
13. Liver stiffness (elastography) after 16 weeks of HYA administration
(Safety endpoints)
1. Incidence of disease HYA administration
2.Complete blood counts at 4, 8, 12, and 16 weeks after HYA administration
3.Hepatic function at 4, 8, 12, and 16 weeks after HYA administration
4.Renal function at 4, 8, 12, and 16 weeks after HYA administration
5. Blood level of Na, K and Cl at 4, 8, 12, and 16 weeks after HYA administration

+81-78-382-6669

Nov. 15, 2024

none