drugset / Trial / NCT07308548
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-10-11
- Primary completion
- 2026-08-13
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HP515 | Unknown | 40 mg | — |
| Subject | HP515 | Unknown | 50 mg | — |
| Subject | HP515 | Unknown | 60 mg | — |