Phase 2a study for NASH

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0007904
• Lead Sponsor: J2H Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

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 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Endpoints: 1) Adverse events (AEs), 2) Vital signs, 3) Laboratory tests, 4) Electrocardiogram (ECG);MRI-PDFF, MRE

Secondary Outcome Measures

Name	Time	Method
Changes in body weight and BMI at the time of 12 weeks from baseline, etc.