Actively Recruiting
A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non-Alcoholic Fatty Liver Disease
Led by Hinova Pharmaceuticals Inc. · Updated on 2025-12-29
80
Participants Needed
2
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of HP515 tablets in people with non-alcoholic fatty liver disease (NAFLD). This Phase IIa clinical trial aims to study the efficacy, safety, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (how the drug affects the body) of HP515. The study also explores how HP515 impacts specific biological markers related to this liver condition. Participants undergo a screening period of 4 weeks, followed by a 12-week treatment phase where they receive different doses of HP515 or a placebo. They are randomly assigned to groups based on body weight, with doses ranging from 40 mg to 60 mg daily. During treatment, participants take tablets once daily and undergo various tests, including blood sampling for drug levels and imaging exams like MRI and FibroScan to monitor liver fat and health. After treatment, a 4-week safety follow-up period is conducted. Throughout the study, participants have multiple visits for assessments including liver imaging at screening, during treatment, and at early withdrawal if applicable. Blood samples are collected fasting before dosing at several time points to study drug behavior. Researchers track changes in liver fat using MRI-PDFF and monitor safety through adverse event reports. The total duration for participants is up to 16 weeks, including screening, treatment, and safety follow-up.
CONDITIONS
Brief 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 informed consent and understand the trial details
- Age between 18 and 65 years inclusive
- Liver fat fraction of 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 from screening start until 28 days after stopping the study drug
- Agreement to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- Known or suspected allergic reactions
- Liver biopsy showing 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
- Major cardiovascular or cerebrovascular events requiring hospitalization within the past year
- History or planned liver transplantation
- Significant diet or exercise changes in past 2 months or weight change over 5%
- Use of drugs affecting liver enzyme CYP2C8 activity within 4 weeks or 5 half-lives
- Pregnant or breastfeeding women
- Contraindications to MRI scans
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily oral medication with HP515 or placebo for 12 weeks while undergoing efficacy and safety evaluations.
Visits at the end of Weeks 2, 6, 8, 10, and 12 for blood sampling and assessments
Duration - 4 weeks
Participants are monitored for safety after completing treatment for an additional 4 weeks.
1 follow-up visit after Week 12 treatment completion
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
W
Wei WL chief physician
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here