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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06297434). StuddyBuddy aggregates publicly available trial information.