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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
HP515 10 mg Tablet
DrugProvided 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
DrugProvided 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
DrugProvided 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
DrugProvided 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
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: HP515 40mg groupExperimental treatment 2 interventions
Group B: HP515 50mg groupExperimental treatment 3 interventions
Group C: HP515 60mg groupExperimental treatment 2 interventions
Group D: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
The relative change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Relative change from baseline is calculated for each subject as 100% x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Time frame
Baseline and Week 12.Secondary outcomes
1
The absolute change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Absolute change from baseline is calculated for each subject as \[(Week 12 Value - Baseline Value)\].
Time frame
Baseline and Week 12.2
At the 12-week treatment period, through MRI-PDFF measurement, the proportion of participants whose liver fat fraction decreased by more than 30% or 50%.
Proportion of subjects with ≥30% or 50% relative reduction in liver fat content by MRI-PDFF at Week 12
Time frame
Week 12.3
The percentage changes of blood lipid
Percent change from baseline of low-density lipoprotein cholesterol (LDL-C)
Time frame
Baseline, up to 12 weeks.4
Number and Percentage of participants with any Treatment Emergent adverse events as assessed by CTCAE v5.0.[Time Frame: up to 16 weeks.]
Safety of HP515 based on Adverse Events and Changes in Laboratory Values、vital signs, physical examination, 12-lead electrocardiogram.
Time frame
Up to 16 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov