Ireland
--:--IST
Recruiting Phase 2

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

NCT07308548 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-10-11
Last updated
2025-12-29

Condition(s) studied

NAFLD (Non-alcoholic Fatty Liver Disease)

Investigational drug(s) / intervention(s)

HP515 10 mg TabletPlacebo of HP515 10 mg TabletHP515 20 mg TabletPlacebo of HP515 20mg Tablet

HP515 10 mg Tablet: Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. HP515 10mg Tablet, qd

Placebo of HP515 10 mg Tablet: Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. Placebo of HP515 10 mg Tablet ,qd , 12 weeks.

HP515 20 mg Tablet: Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; HP515 20 mg Tablet, qd,12 weeks

Placebo of HP515 20mg Tablet: Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; Placebo of HP515 20 mg Tablet, qd,12 weeks

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions. 2. Participants must be aged between 18 and 65 years old, including those at the borderline age. 3. At the screening stage, the liver fat fraction must be ≥ 10% 4. 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. 5. 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: 1. The participants have known or suspected allergic reactions 2. Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis 3. Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%); 4. 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 5. Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease 6. 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; 7. History of liver transplantation or planning to undergo liver transplantation; 8. Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%; 9. 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; 10. Pregnant or lactating women; 11. Participants with contraindications to MRI scans; 12. Participants judged by the investigator to be unsuitable for participation in the study.

Primary outcome measure(s)

  • The relative change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF). — Baseline and Week 12.
    Relative change from baseline is calculated for each subject as 100% x \[(Week 12 Value - Baseline Value)/Baseline Value\].

Trial sites (2)

FacilityCityRegionStatus
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Not Yet Recruiting
Chengdu Seventh People's Hospital Chengdu Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07308548 on ClinicalTrials.gov ↗ ← All trials in China