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

NCT ID: NCT06297434

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2025-11-05

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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J2H-1702 A mg

Group Type EXPERIMENTAL

J2H-1702

Intervention Type DRUG

Orally, once daily before meals

J2H-1702 B mg

Group Type EXPERIMENTAL

J2H-1702

Intervention Type DRUG

Orally, once daily before meals

J2H-1702 C mg

Group Type EXPERIMENTAL

J2H-1702

Intervention Type DRUG

Orally, once daily before meals

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally, once daily before meals

Interventions

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J2H-1702

Orally, once daily before meals

Intervention Type DRUG

J2H-1702

Orally, once daily before meals

Intervention Type DRUG

J2H-1702

Orally, once daily before meals

Intervention Type DRUG

Placebo

Orally, once daily before meals

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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J2H Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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J2H Biotech

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JH-221-201

Identifier Type: -

Identifier Source: org_study_id