Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT06297434
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in results on MRI-PDFF at week12.', 'timeFrame': 'Baseline and week12', 'description': 'The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated.'}, {'measure': 'Changes from baseline in results on MRE at week12.', 'timeFrame': 'Baseline and week12', 'description': 'The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A subject aged ≥19 years to ≤75 years\n2. Meeting all of the following criteria:\n\n * Screening MRI-PDFF with ≥8% steatosis\n * Screening MRE with liver stiffness ≥2.5 kPa\n * ALT or AST ≤250 IU/L at screening\n3. Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study\n4. Voluntarily provide written consent to participate in the study\n\nExclusion Criteria:\n\n1. A subject who has past or current history of liver diseases\n2. A subject who has the following medical or surgical history\n\n * Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class\n3. A subject who has the following concomitant diseases\n\n * liver disease, uncontrolled hypertension, uncontrolled DM, etc.\n4. A subject who has taken the following medications\n\n * Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.\n5. A subject who has taken IP of another study\n6. A subject who does not agree with appropriate methods of contraception'}, 'identificationModule': {'nctId': 'NCT06297434', 'briefTitle': 'Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH', 'organization': {'class': 'INDUSTRY', 'fullName': 'J2H Biotech'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'JH-221-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'J2H-1702 A mg', 'interventionNames': ['Drug: J2H-1702']}, {'type': 'EXPERIMENTAL', 'label': 'J2H-1702 B mg', 'interventionNames': ['Drug: J2H-1702']}, {'type': 'EXPERIMENTAL', 'label': 'J2H-1702 C mg', 'interventionNames': ['Drug: J2H-1702']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'J2H-1702', 'type': 'DRUG', 'description': 'Orally, once daily before meals', 'armGroupLabels': ['J2H-1702 A mg']}, {'name': 'J2H-1702', 'type': 'DRUG', 'description': 'Orally, once daily before meals', 'armGroupLabels': ['J2H-1702 B mg']}, {'name': 'J2H-1702', 'type': 'DRUG', 'description': 'Orally, once daily before meals', 'armGroupLabels': ['J2H-1702 C mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally, once daily before meals', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16684', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'J2H Biotech', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J2H Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}