Actively Recruiting
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Led by Hinova Pharmaceuticals Inc. · Updated on 2025-12-29
80
Participants Needed
2
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign the informed consent form and fully understand the trial content, process, and possible adverse reactions.
- Aged between 18 and 65 years old, including those at the borderline age.
- Liver fat fraction must be 10% or higher at screening.
- Female participants must not donate eggs from screening start until 28 days after stopping the study drug; male participants must not donate sperm during the same period.
- Participants must agree to use effective contraception during the study and for 6 months after the last dose.
You will not qualify if you...
- Known or suspected allergic reactions.
- Liver biopsy indicating cirrhosis or clinical diagnosis of cirrhosis.
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c 8.0% or higher).
- Other liver or gallbladder diseases that may affect safety or efficacy.
- Clinically significant thyroid function abnormalities or history of thyroid disease.
- Cardiovascular or cerebrovascular events requiring hospitalization within the past year.
- History or planned liver transplantation.
- Significant diet or exercise changes or weight change over 5% in past 2 months.
- Use of drugs affecting liver enzyme CYP2C8 within 4 weeks or five half-lives.
- Pregnant or lactating women.
- Contraindications to MRI scans.
- Investigator judgment of unsuitability for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
2
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yang Ming YM Chief physician
CONTACT
W
Wei WL chief physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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