Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04342793
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of ALS-L1023 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608553', 'term': 'ALS-L1023'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver fat percentage measured by MRI-PDFF', 'timeFrame': 'baseline, 24 weeks', 'description': 'Liver fat is measured by MRI-PDFF'}, {'measure': 'Change in liver fibrosis measured by MRE', 'timeFrame': 'baseline, 24 weeks', 'description': 'Liver fibrosis is measured by Magnetic Resonance Enterography'}, {'measure': 'Change in visceral fat area measured by MRI', 'timeFrame': 'baseline, 24weeks', 'description': 'Visceral fat area is measured by MRI'}, {'measure': 'Changes in serum concentrations of ALT and AST', 'timeFrame': 'baseline, 24weeks', 'description': 'ALT and AST concentrations in serum are measured'}], 'secondaryOutcomes': [{'measure': 'Change in serum concentration of Pro-C3', 'timeFrame': 'baseline, 24weeks', 'description': 'Pro-C3 concentration in serum is measured'}, {'measure': 'Change in serum concentration of CK-18', 'timeFrame': 'baseline, 24weeks', 'description': 'CK-18 concentration in serum is measured'}, {'measure': 'Change in insulin sensitivity determined by HOMA-IR', 'timeFrame': 'baseline, 24weeks', 'description': 'Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance'}, {'measure': 'Change in serum concentration of Leptin', 'timeFrame': 'baseline, 24weeks', 'description': 'Concentration of Leptin in serum is measured'}, {'measure': 'Changes in serum concentrations of ALT and AST', 'timeFrame': 'baseline, 8weeks, 16weeks', 'description': 'ALT and AST concentrations in serum are measured'}, {'measure': 'Changes in serum concentrations of TG and TC', 'timeFrame': 'baseline, 8weeks, 16weeks, 24weeks', 'description': 'Triglyceride and Total Cholesterol concentrations in serum are measured'}, {'measure': 'Change of NAFLD fibrosis score(NFS)', 'timeFrame': 'baseline, 8weeks, 16weeks, 24weeks', 'description': 'NFS is measured'}, {'measure': 'Change in serum concentration of Ghrelin', 'timeFrame': 'baseline, 24weeks', 'description': 'Concentration of Ghrelin in serum is measured'}, {'measure': 'Change in serum concentration of Adiponection', 'timeFrame': 'baseline, 24weeks', 'description': 'Concentration of Adiponection in serum is measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis', 'detailedDescription': 'Besides the main objectives, there are other objectives as follows:\n\n1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE\n2. To determine optimized dose of ALS-L1023 in NASH disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women ages 19 and over, under 75 years of age\n* Patients diagnosed with NAFLD on abdominal ultrasonography and MRI\n* Patients show presence of hepatic fat fraction as defined by ≥ 8% on MRI-PDFF and liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening\n\nExclusion Criteria:\n\n* Any subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 2 year prior to screening will be excluded\n* Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, viral hepatitis A, B, alcoholic liver disease\n* Uncontrolled diabetes mellitus as defined by a HbA1c ≥ 9.0％ at Screening\n* Patients who are allergic or hypersensitive to the drug or its constituents\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04342793', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH', 'organization': {'class': 'INDUSTRY', 'fullName': 'AngioLab, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': 'AL101-NASH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'ALS-L1023 1,200mg', 'description': 'ALS-L1023 600mg twice a day', 'interventionNames': ['Drug: ALS-L1023 1,200mg']}, {'type': 'EXPERIMENTAL', 'label': 'ALS-L1023 1,800mg', 'description': 'ALS-L1023 900mg twice a day', 'interventionNames': ['Drug: ALS-L1023 1,800mg']}], 'interventions': [{'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'ALS-L1023 1,200mg', 'type': 'DRUG', 'otherNames': ['ALS-L1023 tablet'], 'description': 'ALS-L1023', 'armGroupLabels': ['ALS-L1023 1,200mg']}, {'name': 'ALS-L1023 1,800mg', 'type': 'DRUG', 'otherNames': ['ALS-L1023 tablet'], 'description': 'ALS-L1023', 'armGroupLabels': ['ALS-L1023 1,800mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Won Jun, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AngioLab, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}