drugset / Trial / NCT07308548

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

NCT07308548 ↗

Phase 2 Recruiting 80 enrolled Hinova Pharmaceuticals Inc.
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

EvaluationDrugModalityDoseRoute
Subject HP515 Unknown 40 mg —
Subject HP515 Unknown 50 mg —
Subject HP515 Unknown 60 mg —

Indications