A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )

Korábbi kezelés

• Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease
• Within the previous 1 year, had myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack, or other cardiovascular and cerebrovascular events that led to hospitalization;
• Participants who used drugs that changed the activity of CYP2C8 of liver enzymes within 4 weeks or 5 half-lives (whichever is longer), including strong inhibitors and inducers of liver metabolic enzymes;

Más betegség

• The participants have known or suspected allergic reactions
• History of liver transplantation or planning to undergo liver transplantation;

Laborértékek

• Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);
• Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation

Egyéb

• Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis
• Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%;
• Pregnant or lactating women;
• Participants with contraindications to MRI scans;
• Participants judged by the investigator to be unsuitable for participation in the study.

• Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.
• Participants must be aged between 18 and 65 years old, including those at the borderline age.
• At the screening stage, the liver fat fraction must be ≥ 10%
• Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.
• Participants must agree to use contraception during the study period and for the next 6 months after the last administration of the study drug, and must agree to continuously use effective contraceptive measures.