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

NCT06297434 | Completed Phase 2

• 1 other identifier: JH-221-201
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

J2H-1702 A mg

EXPERIMENTAL

Drug: J2H-1702

J2H-1702 B mg

EXPERIMENTAL

Drug: J2H-1702

J2H-1702 C mg

EXPERIMENTAL

Drug: J2H-1702

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

J2H-1702 DRUG

Orally, once daily before meals

J2H-1702 A mg

Placebo DRUG

Orally, once daily before meals

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject aged ≥19 years to ≤75 years
• 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
• Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
• Voluntarily provide written consent to participate in the study

You may not qualify if:

• A subject who has past or current history of liver diseases
• 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
• A subject who has the following concomitant diseases
• liver disease, uncontrolled hypertension, uncontrolled DM, etc.
• A subject who has taken the following medications
• Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
• A subject who has taken IP of another study
• A subject who does not agree with appropriate methods of contraception

Sponsors & Collaborators

• J2H Biotech: lead

Study Sites (1)

J2H Biotech

Suwon, Gyeonggi-do, 16684, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 7, 2024
• Study Start: February 15, 2023
• Primary Completion: June 26, 2025
• Study Completion: November 5, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)