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).

未提供0 个研究点目标入组 35 人开始时间: 2025年1月27日最近更新: 2025年1月31日

试验速览

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•Persons diagnosed with NAFLD (MASLD) (regardless of gender) who are between 20 and 70 years of age at the time consent is obtained.
•patients with fatty liver on abdominal ultrasonography
•patients with an ALT level of 35 U/L or higher
•patients with ALT level >= 35 U/L and no decrease of >= 10% after at least 3 months of diet and exercise therapy
•patients whose alcohol intake (net alcohol) is less than 30 g/day for men and 20 g/day for women
•patients with negative HBs antigen and HCV antibody
•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
•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)
•patients with severe renal dysfunction (eGFR less than 30)
•patients with cancer or who have undergone any treatment for cancer within the past 5 years
•patients with poor glycemic control (HbA1c > 8.5%)
•patients with heart failure or a history of coronary artery disease (myocardial infarction, angina pectoris) or cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
•patients who are pregnant or may be pregnant, and lactating patients
•patients who have been taking oral or intravenous steroids for more than 1 month
•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
•patients who have lost 5% of their body weight within 3 months prior to obtaining consent
•other patients deemed inappropriate by the investigator of this clinical study.

ALT after 16 weeks of HYA administration

发起方

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