Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 12:20 PM
Study NCT ID:
NCT05118360
Status:
WITHDRAWN
Last Update Posted:
2024-09-27
First Post:
2021-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults 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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Randomized in 2:1 ratio to receive either oral ASC41 2 mg or oral matching placebo. Randomized in 2:1 ratio to receive either oral ASC41 4 mg or oral matching placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study has been cancelled due to business reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52', 'timeFrame': 'Baseline to Week 52'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.', 'timeFrame': 'Baseline to Week 12 and Week 52'}, {'measure': 'Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects', 'timeFrame': 'Baseline to Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAFLD', 'Phase 2', 'Thyroid hormone receptor agonist', 'NASH', 'ASC41'], 'conditions': ['Nonalcoholic Steatohepatitis (NASH)']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Presence of ≥ 8% liver fat content on screening MRI-PDFF.\n* Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.\n* Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.\n\nKey Exclusion Criteria:\n\n* Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.\n* Evidence of other causes of chronic liver disease.\n* Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.\n* Any contraindications to a MRI scan.\n* Treatment with vitamin E (unless stable dose of \\< 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.\n* Known history of alcohol or other substance abuse within the last year or at any time during the study.\n* Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.\n* Known positivity for antibody to Human Immunodeficiency Virus (HIV).'}, 'identificationModule': {'nctId': 'NCT05118360', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': 'ASC41-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1-ASC41 2mg', 'description': 'ASC41 2mg for 52 weeks.', 'interventionNames': ['Drug: ASC41 2 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part1-placebo', 'description': 'Matching placebo for 52 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2-ASC41 4mg', 'description': 'ASC41 4 mg for 52 weeks.', 'interventionNames': ['Drug: ASC41 4 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part2-placebo', 'description': 'Matching placebo for 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASC41 2 mg', 'type': 'DRUG', 'description': '2mg of ASC41 orally once daily for 52 weeks', 'armGroupLabels': ['Part 1-ASC41 2mg']}, {'name': 'ASC41 4 mg', 'type': 'DRUG', 'description': '4mg of ASC41 orally once daily for 52 weeks', 'armGroupLabels': ['Part 2-ASC41 4mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo orally once daily for 52 weeks.', 'armGroupLabels': ['Part1-placebo', 'Part2-placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gannex Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}