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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-alcoholic fatty liver disease and a liver fat fraction of 10% or more. It tests HP515 tablets against placebo.
- Age
- 18 to 65 years old, including 18 and 65.
- Sex
- All sexes can join.
- Disease stage
- Non-alcoholic fatty liver disease with a liver fat fraction of 10% or more at screening. People with cirrhosis cannot join.
- Earlier treatment
- No drugs that change the activity of the liver enzyme CYP2C8 in the 4 weeks before, or 5 half-lives, whichever is longer. This includes strong inhibitors and inducers.
- Biomarker or test result
- Liver fat fraction of 10% or more at screening.
Main reasons for not taking part
- Cirrhosis, proven by liver biopsy or diagnosed clinically
- Type 1 diabetes, or poorly controlled type 2 diabetes (HbA1c 8.0% (64 mmol/mol) or more)
- Pregnant or breastfeeding women
- Past or planned liver transplant
- Heart or brain events needing hospital care in the past 1 year, such as heart attack or stroke
Read by machine on 9 November 2026.
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.