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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of J2H-1702 for Non-alcoholic Steatohepatitis

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Steatohepatitis
• Intervention / Treatment: Drug: J2H-1702; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16684
      • J2H Biotech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Orally, once daily before meals
Experimental: J2H-1702 A mg	Drug: J2H-1702; Orally, once daily before meals
Experimental: J2H-1702 B mg	Drug: J2H-1702; Orally, once daily before meals
Experimental: J2H-1702 C mg	Drug: J2H-1702; Orally, once daily before meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: J2H Biotech

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: JH-221-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No