Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH

Phase 2

Recruiting

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: J2H-1702; Drug: Placebo

• Registration Number: NCT06297434
• Lead Sponsor: J2H Biotech

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).

Study Timeline

• Study Start: 2023-02-15
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-04-15
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
J2H-1702 A mg	J2H-1702	-
J2H-1702 B mg	J2H-1702	-
J2H-1702 C mg	J2H-1702	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

J2H Biotech; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of