Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 5:35 AM
Study NCT ID:
NCT06318169
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52', 'timeFrame': 'Week 52', 'description': 'Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis'}, {'measure': 'Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52', 'timeFrame': 'Week 52', 'description': 'Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.'}, {'measure': 'Time to First Occurrence of Disease Progression', 'timeFrame': 'Up to 5 years', 'description': 'Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Alanine Aminotransferase at Week 52', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52', 'timeFrame': 'Baseline, Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Diseases', 'Fatty Liver', 'Digestive System Diseases', 'Metabolic diseases', 'Metabolic Dysfunction-Associated Steatohepatitis', 'MASH', 'Steatohepatitis', 'Metabolic dysfunction-associated steatotic liver disease', 'MASLD', 'Nonalcoholic fatty liver disease', 'NAFLD', 'Fibrosis'], 'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis']}, 'descriptionModule': {'briefSummary': 'The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\\^2) (≥23 kg/m\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06318169', 'briefTitle': 'A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)', 'organization': {'class': 'INDUSTRY', 'fullName': '89bio, Inc.'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis', 'orgStudyIdInfo': {'id': 'BIO89-100-131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegozafermin Regimen 1', 'interventionNames': ['Biological: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Pegozafermin Regimen 2', 'interventionNames': ['Biological: Pegozafermin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched Placebo will be administered in Regimens 1 and 2.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pegozafermin', 'type': 'BIOLOGICAL', 'otherNames': ['BIO89-100'], 'description': 'Subcutaneous injection', 'armGroupLabels': ['Pegozafermin Regimen 1', 'Pegozafermin Regimen 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': '89bio Clinical Study Site', 'role': 'CONTACT'}], 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': '89bio Clinical Study Site', 'role': 'CONTACT'}], 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': '89bio Clinical Study Site', 'role': 'CONTACT'}], 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '85036', 'city': 'Glendale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': '89bio Clinical Study Site', 'role': 'CONTACT'}], 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': '89bio Clinical Study Site', 'role': 'CONTACT'}], 'facility': '89bio Clinical Study Site', 'geoPoint': 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