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Completed
NCT06297434
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
Conditions: Non-alcoholic Steatohepatitis
Sex: All
Ages: 19 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 87
Sponsor: J2H Biotech
Location: Dong-A University Hospital Busan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06297434). StuddyBuddy aggregates publicly available trial information.