Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03603704
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2018-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Cohort 3 is open-label.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11-01', 'completionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 28', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590', 'timeFrame': 'Baseline through Day 28', 'description': 'PK: Cmax of LY3209590'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590', 'timeFrame': 'Baseline through Day 28', 'description': 'PK: AUC of LY3209590'}, {'measure': 'Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline through Day 15', 'description': 'PD: Change from Baseline in Fasting Plasma Glucose'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '39928225', 'type': 'DERIVED', 'citation': 'Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have T2DM diagnosed at least 1 year ago\n* Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and \\<7.0% with FPG ≥144 mg/dL at screening\n* Have body weight ≥54 kilograms and a body mass index \\>18.5 and ≤40.0 kilograms per square meter at screening\n\nExclusion Criteria:\n\n* Have received a total daily dose of insulin \\>1.2 units per kilogram at screening\n* Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening\n* Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction\n* Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study'}, 'identificationModule': {'nctId': 'NCT03603704', 'briefTitle': 'A Study of LY3209590 in Japanese Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '16552'}, 'secondaryIdInfos': [{'id': 'I8H-JE-BDCF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3209590', 'description': 'Insulin naïve participants with Type 2 Diabetes Mellitus received 5 mg and 10 mg LY3209590 administered subcutaneously (SC) in Cohort 1 and 2 respectively.\n\nParticipants with T2DM received 20 mg LY3209590 administered subcutaneously in Cohort 3.', 'interventionNames': ['Drug: LY3209590']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Participants from Cohort 1 and 2 received Placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3209590', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3209590']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '192-0071', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'P-one clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '130-0004', 'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sumida Hospital'}, {'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Hakata Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}