Evaluating J2H-1702 for treating Non-alcoholic Steatohepatitis
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
This study is testing if a new medication called J2H-1702 can improve liver health in people with Non-alcoholic Steatohepatitis (NASH) compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | J2H Biotech Industry-sponsored |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06297434 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and explores the efficacy of J2H-1702 in patients with Non-alcoholic Steatohepatitis (NASH). Participants will be randomly assigned to receive different doses of J2H-1702 or a placebo for 12 weeks. The study will assess safety and efficacy at multiple time points after treatment. The aim is to determine how well J2H-1702 works compared to a placebo in improving liver health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 75 with specific liver health indicators and willing to maintain their lifestyle during the study.
Not a fit: Patients with a history of liver diseases or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from NASH.
How similar studies have performed: While there have been studies on NASH treatments, the specific approach of J2H-1702 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Suwon, Gyeonggi-do
- J2H Biotech — Suwon, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Eunji Byeon
- Email: ejb@j2hbio.com
- Phone: +82-10-8012-1074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.