Tests HP515 tablets in adults with fatty liver disease
Tests HP515 tablets against placebo in adults with non-alcoholic fatty liver disease.
Plain-language title generated from the registry record
Registry title: A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Key facts
- Where
- Beijing and Chengdu, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07308548, who can take part
Where in China
- Beijing Tsinghua Changgung HospitalBeijing, ChinaNot yet recruiting
- Chengdu Seventh People's HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hinova Pharmaceuticals Inc.
- Trial code
- NCT07308548
- Record updated
- 29 December 2025
- Original description
Primary Objective:Read full original descriptionShow less
A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease
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.
Inclusion: 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: 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; The participants have known or suspected allergic reactions; History of liver transplantation or planning to undergo liver transplantation; 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; 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.