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

NCT07308548 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-29

No results posted yet for this 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.

Conditions

  • NAFLD (Non-alcoholic Fatty Liver Disease)

Interventions

DRUG

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

DRUG

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.

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Hinova Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-11
Primary Completion
2026-08-13
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07308548 on ClinicalTrials.gov