Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-28 @ 9:57 PM
Study NCT ID:
NCT05338034
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2021-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2a Study of HPG1860 in Subjects With 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'], 'maskingDescription': 'During this study, subjects, investigators, the Sponsor, and the clinical research organization (CRO) (except specific vendors whose role in study conduct requires their unblinding, eg, personnel operationally associated with the interactive response technology \\[IRT\\]) will be blinded to the study intervention assignment. Study team personnel will remain blinded throughout the study with the exception of a Sponsor Committee who will review interim analysis results and make decisions regarding dropping and/or adding a treatment cohort and an unblinded study team member assigned to monitor that at least 6 subjects in each dose cohort had serial PK measurements taken.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2021-10-24', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of treatment', 'timeFrame': '12 weeks', 'description': 'Number of participants Treatment-emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'liver fat content', 'timeFrame': '12 week', 'description': 'Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12'}, {'measure': 'Percentage of subjects with ≥30% reduction in LFC from baseline', 'timeFrame': '4 week and 12 week', 'description': 'measured by MRI-PDFF at Week 4 and Week 12'}, {'measure': 'Change from baseline (CFB) in liver fat content (LFC) at 4 week', 'timeFrame': '4 week', 'description': 'measured by MRI-PDFF at Week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NASH'], 'conditions': ['NASH - Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.', 'detailedDescription': 'This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males and females between 18 and 75 years of age; inclusive based on the date of Screening', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study-specific procedure.\n2. Males and females between 18 and 75 years of age\n3. Nonpregnant, nonlactating women.\n4. Male subjects must agree to utilize a highly effective method of contraception.\n5. Body mass index (BMI) of ≥25 kg/m2 at Screening.\n6. Non-cirrhotic NASH subjects.\n7. NASH subjects with hepatic fat assessed by a central reader\n8. Willing and able to adhere to study restrictions and agree to comply with study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females\n2. Current significant alcohol consumption\n3. Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor\n4. Renal dysfunction or nephritic syndrome or a history of nephritis\n5. Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia\n6. Uncontrolled hypertension\n7. Type 1 diabetes or uncontrolled T2DM\n8. Uncontrolled hypothyroidism\n9. Liver transplant and/or other significant liver disease or dysfunction\n10. HIV antibody positive\n11. Known hypersensitivity or formulation excipient\n12. Gastrointestinal conditions or procedures that may affect drug absorption\n13. Hematologic or coagulation disorders\n14. Unstable weight within the last 3 months\n15. Active malignancy\n16. Unexplained creatine kinase (CK) \\>3 × ULN\n17. Blood donation, blood transfusion\n18. Unable to undergo or contraindication to MRI procedure\n19. A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study."}, 'identificationModule': {'nctId': 'NCT05338034', 'acronym': 'RISE', 'briefTitle': 'Phase 2a Study of HPG1860 in Subjects With NASH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hepagene (Shanghai) Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Parallel Group Phase 2a Study to Evaluate the Efficacy and Safety of HPG1860 in Subjects With Nonalcoholic Steatohepatitis', 'orgStudyIdInfo': {'id': 'HPG1860-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPG1860 3 mg', 'description': '20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.', 'interventionNames': ['Drug: HPG1860']}, {'type': 'EXPERIMENTAL', 'label': 'HPG1860 5 mg', 'description': '20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.', 'interventionNames': ['Drug: HPG1860']}, {'type': 'EXPERIMENTAL', 'label': 'HPG1860 8 mg', 'description': '20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.', 'interventionNames': ['Drug: HPG1860']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 subjects will be treated with Placebo once daily at a similar time with or without food.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HPG1860', 'type': 'DRUG', 'description': 'The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.', 'armGroupLabels': ['HPG1860 3 mg', 'HPG1860 5 mg', 'HPG1860 8 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78240', 'city': 'Texas City', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Research Institute (STRI)', 'geoPoint': {'lat': 29.38385, 'lon': -94.9027}}], 'overallOfficials': [{'name': 'Naim Alkhouri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona Liver Health - Tucson'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'still pending'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepagene (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}