Clinical Trial

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

Study acronym: NASH/MASH
Recruiting Phase 2
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Record status
This record was last updated December 29, 2025 (before its estimated August 13, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07308548
Lead Sponsor Hinova Pharmaceuticals Inc.
Conditions NAFLD (Non-alcoholic Fatty Liver Disease)
Enrollment 80 participants
Start Date 2025-10-11
Primary Completion 2026-08-13 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-29