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

J2H Biotech

Status and phase: Enrolling; Phase 2

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: J2H-1702; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06297434

JH-221-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

J2H-1702 A mg

Experimental group

Treatment:

Drug: J2H-1702

Drug: J2H-1702

Drug: J2H-1702

J2H-1702 B mg

Experimental group

Treatment:

Drug: J2H-1702

Drug: J2H-1702

Drug: J2H-1702

J2H-1702 C mg

Experimental group

Treatment:

Drug: J2H-1702

Drug: J2H-1702

Drug: J2H-1702

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo