Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06869018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Day 1 Through Day 127', 'description': 'A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492', 'timeFrame': 'Day 1 Through Day 127', 'description': 'PK: AUC of LY3549492'}, {'measure': 'PK: Maximum Concentration (Cmax) of LY3549492', 'timeFrame': 'Day 1 Through Day 127', 'description': 'PK: Cmax of LY3549492'}, {'measure': 'Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Day 1 Through Day 127', 'description': 'PD: Change from Baseline in Hemoglobin A1c (HbA1c)'}, {'measure': 'PD: Change from Baseline in Body Weight', 'timeFrame': 'Day 1 Through Day 127', 'description': 'PD: Change from Baseline in Body Weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2'], 'conditions': ['Healthy', 'Type 2 Diabetes Mellitus (T2D)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A:\n\n* Participants with T2DM for at least 6 months\n* With an HbA1c value:\n\n * equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR\n * equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications\n* Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change\n\nPart B:\n\n* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results\n\nExclusion Criteria:\n\n* Have a known clinically significant gastric emptying abnormality\n* Have a 12-lead electrocardiogram (ECG) abnormality\n* Have an abnormal blood pressure or pulse rate\n* Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug\n* Have a history of chronic medical conditions involving the heart, liver, or kidneys'}, 'identificationModule': {'nctId': 'NCT06869018', 'briefTitle': 'A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus and Healthy Japanese Participants', 'orgStudyIdInfo': {'id': '27338'}, 'secondaryIdInfos': [{'id': 'J3H JE GZNG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3549492 Part A', 'description': 'LY3549492 administered orally', 'interventionNames': ['Drug: LY3549492']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Part B', 'description': 'LY3549492 administered orally', 'interventionNames': ['Drug: LY3549492']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A', 'description': 'Placebo administered orally', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B', 'description': 'Placebo administered orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3549492', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3549492 Part A', 'LY3549492 Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo Part A', 'Placebo Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Hakata Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '192-0071', 'city': 'Hachiōji', 'country': 'Japan', 'facility': 'P-One Clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '532-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '160-0004', 'city': 'Shinjuku-ku', 'country': 'Japan', 'facility': 'Clinical Research Hospital Tokyo'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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'}}}}