Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:27 PM
Study NCT ID:
NCT04857606
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Incidence of Treatment-emergent Adverse Events', 'timeFrame': 'Day 1 to Day 150'}, {'measure': 'Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes', 'timeFrame': 'Baseline to Day 150'}, {'measure': 'Subject Incidence of Clinically Significant Change from Baseline in Vital Signs', 'timeFrame': 'Baseline to Day 150'}, {'measure': 'Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)', 'timeFrame': 'Baseline to Day 113'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of AMG 609', 'timeFrame': 'Up to Day 150'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) of AMG 609', 'timeFrame': 'Up to Day 150'}, {'measure': 'Area Under the Concentration Time Curve (AUC) of AMG 609', 'timeFrame': 'Up to Day 150'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single ascending dose', 'NAFLD', 'AMG 609'], 'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Inclusion Criteria\n\n * Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent\n * Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2\n * Liver steatosis, measured by MRI-PDFF, greater than 8%\n* Exclusion Criteria\n\n * Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma).\n * Significantly elevated LFTs (more than 1.5x ULN)\n * Uncontrolled diabetes (HgbA1c \\> 9%) or uncontrolled hypertension.\n * History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma.\n * Females of reproductive potential."}, 'identificationModule': {'nctId': 'NCT04857606', 'briefTitle': 'Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '20200001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 609', 'description': 'Up to 7 cohorts ranging by various dose levels.', 'interventionNames': ['Drug: AMG 609']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants will receive the matching placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMG 609', 'type': 'DRUG', 'description': 'Single dose of AMG 609 administered as a subcutaneous injection.', 'armGroupLabels': ['AMG 609']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose of placebo administered as a subcutaneous injection.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health - Arizona Liver Health', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'ProSciento Incorporated', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Inland Empire Liver Foundation', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Translational Clinical Research LLC', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}