A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHinova Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.
Participants must be aged between 18 and 65 years old, including those at the borderline age.
At the screening stage, the liver fat fraction must be ≥ 10%
Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.
Disqualifiers
The participants have known or suspected allergic reactions
Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis
Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);
Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation
Trial design
Treatments tested in this trial
- HP515 10 mg Tablet
- Placebo of HP515 10 mg Tablet
- HP515 20 mg Tablet
- Placebo of HP515 20mg Tablet
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov