Non-alcoholic Steatohepatitis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGJ2H-1702
Orally, once daily before meals
DRUGPlacebo
Orally, once daily before meals
Sponsors
J2H Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A subject aged ≥19 years to ≤75 years 2. Meeting all of the following criteria: * Screening MRI-PDFF with ≥8% steatosis * Screening MRE with liver stiffness ≥2.5 kPa * ALT or AST ≤250 IU/L at screening 3. Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study 4. Voluntarily provide written consent to participate in the study
Exclusion criteria
1. A subject who has past or current history of liver diseases 2. A subject who has the following medical or surgical history * Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class 3. A subject who has the following concomitant diseases * liver disease, uncontrolled hypertension, uncontrolled DM, etc. 4. A subject who has taken the following medications * Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc. 5. A subject who has taken IP of another study 6. A subject who does not agree with appropriate methods of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in results on MRI-PDFF at week12. | Baseline and week12 | The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated. |
| Changes from baseline in results on MRE at week12. | Baseline and week12 | The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated. |
Countries
South Korea
Outcome results
None listed