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The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.
Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J2H-1702 A mg | Experimental |
| |
| J2H-1702 B mg | Experimental |
| |
| J2H-1702 C mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J2H-1702 | Drug | Orally, once daily before meals |
| |
| J2H-1702 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in results on MRI-PDFF at week12. | The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated. | Baseline and week12 |
| Changes from baseline in results on MRE at week12. | The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated. | Baseline and week12 |
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Inclusion Criteria:
A subject aged ≥19 years to ≤75 years
Meeting all of the following criteria:
Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
Voluntarily provide written consent to participate in the study
Exclusion Criteria:
A subject who has past or current history of liver diseases
A subject who has the following medical or surgical history
A subject who has the following concomitant diseases
A subject who has taken the following medications
A subject who has taken IP of another study
A subject who does not agree with appropriate methods of contraception
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J2H Biotech | Suwon | Gyeonggi-do | 16684 | South Korea |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Orally, once daily before meals |
|
| J2H-1702 | Drug | Orally, once daily before meals |
|
| Placebo | Drug | Orally, once daily before meals |
|