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A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Sponsor: Hinova Pharmaceuticals Inc.
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.
Official title: A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-11
Completion Date
2026-12-31
Last Updated
2025-12-29
Healthy Volunteers
No
Interventions
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
Locations (2)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China