A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Recruiting · NCT07308548 · Interventional (participants receive a specific treatment) · Lead sponsor: Hinova Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Primary Objective: • To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease. Secondary objectives: * To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease; * To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic fatty liver disease; * To evaluate the pharmacodynamic effects of HP515 tablets in participants with non-alcoholic fatty liver disease; Exploratory objective: • To evaluate the impact of HP515 tablets on target markers in participants with non-alcoholic fatty liver disease. The study includes a screening period of 4 weeks, a treatment period of 12 weeks, and a safety follow-up period of 4 weeks.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- The participants have known or suspected allergic reactions
- Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis
- 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
- 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;
- History of liver transplantation or planning to undergo liver transplantation;
- Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%;
- 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;
- Pregnant or lactating women;
- Participants with contraindications to MRI scans;
- Participants judged by the investigator to be unsuitable for participation in the study.
Where it is running
2 locations listed.
- Beijing Tsinghua Changgung Hospital - Beijing, Beijing Municipality, China
- Chengdu Seventh People's Hospital - Chengdu, Sichuan, China