Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-15 @ 12:28 AM
Study NCT ID:
NCT05327127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2022-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Sponsor:
Organization:
Raw JSON
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The worsening of fibrosis is defined as any numerical increase in the stage.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Related Adverse Events (AE)', 'timeFrame': '52 Weeks', 'description': 'Time frame is 52 weeks unless an unresolved AE is still being followed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NASH']}, 'descriptionModule': {'briefSummary': 'A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and comply with study procedures and give written informed consent\n* Age ≥18 years\n* NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization\n* Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization\n* Meet all inclusion criteria outlined in clinical study protocol\n\nExclusion Criteria:\n\n* Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study\n* Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol\n* Evidence of other forms of chronic liver disease as defined in clinical study protocol\n* Does not meet any other exclusion criteria outlined in clinical study protocol'}, 'identificationModule': {'nctId': 'NCT05327127', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis', 'orgStudyIdInfo': {'id': 'K-001-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'K-001', 'description': 'K-877-ER and CSG452 Once daily (QD)', 'interventionNames': ['Drug: K-877-ER', 'Drug: CSG452']}, {'type': 'EXPERIMENTAL', 'label': 'K-877-ER', 'description': 'K-877-ER and CSG452 Placebo QD', 'interventionNames': ['Drug: K-877-ER', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CSG452', 'description': 'CSG452 and K-877-ER Placebo QD', 'interventionNames': ['Drug: CSG452', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'K-877-ER', 'type': 'DRUG', 'description': 'K-877-ER tablet', 'armGroupLabels': ['K-001', 'K-877-ER']}, {'name': 'CSG452', 'type': 'DRUG', 'description': 'CSG452 tablet', 'armGroupLabels': ['CSG452', 'K-001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['CSG452', 'K-877-ER', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Adobe Clinical Research, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Liver Health', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arcare Center for Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95648', 'city': 'Lincoln', 'state': 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