A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Chengdu Seventh People's Hospital | Chengdu | Sichuan | Recruiting |
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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