Non-alcoholic SteatohepatitisPhase 2NCT06297434
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
A Phase 2 study testing J2H-1702 in people with Non-alcoholic Steatohepatitis, run by J2H Biotech at 11 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- J2H-1702
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 15 Feb 2023to 5 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject aged ≥19 years to ≤75 years
- 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
- Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
- Voluntarily provide written consent to participate in the study
Who cannot join
- A subject who has past or current history of liver diseases
- 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
- A subject who has the following concomitant diseases
- liver disease, uncontrolled hypertension, uncontrolled DM, etc.
- A subject who has taken the following medications
Show all 9Show fewer
- Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
- A subject who has taken IP of another study
- A subject who does not agree with appropriate methods of contraception
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Dong-A University Hospital
Busan
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Hallym University Sacred Heart Hospital
Gyeonggi-do
Gyeongsang National University Hospital
Gyeongsang
Inha University Hospital
Incheon
Chung Ang university hospital
Seoul
Hanyang University Hospital
Seoul
Kyung Hee University Hospital
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
Soonchunhyang University Seoul Hospital
Seoul
About this study
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
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.
Read the detailed 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).
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- J2H-1702, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J2H-1702Drug
Orally, once daily before meals
J2H-1702Drug
Orally, once daily before meals
J2H-1702Drug
Orally, once daily before meals
PlaceboDrug
Orally, once daily before meals
| Study group | Role | What they receive |
|---|---|---|
| J2H-1702 A mg | Experimental | Not described Receives: Drug: J2H-1702 |
| J2H-1702 B mg | Experimental | Not described Receives: Drug: J2H-1702 |
| J2H-1702 C mg | Experimental | Not described Receives: Drug: J2H-1702 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week12
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.
Measured: Baseline and week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Feb 2023
- Primary completion26 Jun 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- J2H Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297434
- Sponsor's protocol ID
- JH-221-201
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06297434
- Acronym / sponsor ID
- JH-221-201
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- J2H BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| J2H-1702 A mg | Experimental | Drug: J2H-1702 |
| J2H-1702 B mg | Experimental | Drug: J2H-1702 |
| J2H-1702 C mg | Experimental | Drug: J2H-1702 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A subject aged ≥19 years to ≤75 years
- Meeting all of the following criteria:
- Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
- Voluntarily provide written consent to participate in the study
Key exclusion criteria (9 listed)
- A subject who has past or current history of liver diseases
- A subject who has the following medical or surgical history
- A subject who has the following concomitant diseases
- A subject who has taken the following medications
- A subject who has taken IP of another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| J2H-1702Orally, once daily before meals | Drug | J2H-1702 A mg |
| J2H-1702Orally, once daily before meals | Drug | J2H-1702 B mg |
| J2H-1702Orally, once daily before meals | Drug | J2H-1702 C mg |
| PlaceboOrally, once daily before meals | Drug | Placebo |
Primary outcome
Changes from baseline in results on MRI-PDFF at week12.
Time frame: Baseline and week12
The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated.
Changes from baseline in results on MRE at week12.
Time frame: Baseline and week12
The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing J2H-1702 in people with Non-alcoholic Steatohepatitis, run by J2H Biotech at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in results on MRI-PDFF at week12. (time frame: Baseline and week12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.