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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297434
• Other study ID #: JH-221-201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: J2H Biotech
• Contact: Eunji Byeon
• Phone: +82-10-8012-1074
• Email: ejb[@]j2hbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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 11ß-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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• J2H-1702
Orally, once daily before meals
• J2H-1702
Orally, once daily before meals
• J2H-1702
Orally, once daily before meals
• Placebo
Orally, once daily before meals

Locations

Country	Name	City	State
Korea, Republic of	J2H Biotech	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
J2H Biotech

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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