Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 11:01 AM
Study NCT ID:
NCT04823208
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', '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 106', '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 Concentration (Cmax) of LY3437943', 'timeFrame': 'Predose on Day 1 through Day 81', 'description': 'PK: Cmax of LY3437943'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943', 'timeFrame': 'Predose on Day 1 through Day 81', 'description': 'PK: AUC of LY3437943'}, {'measure': 'Change from Baseline in Mean Daily Plasma Glucose (PG)', 'timeFrame': 'Baseline through Day 80', 'description': 'Change from baseline in mean daily PG from 6-point PG profile'}, {'measure': 'Change from Baseline in Glycated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline through Day 78', 'description': 'Change from Baseline in HbA1c'}, {'measure': 'Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline through Day 78', 'description': 'Change from Baseline in Fasting Glucose'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline through Day 78', 'description': 'Change from Baseline in Body Weight'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/283676', 'label': 'A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year.\n* Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at lead-in and screening\n* Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m²), inclusive, and a body weight of at least 54 kilograms (Kg).\n* Males and females not of childbearing potential\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus (T1DM)\n* Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization\n* Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \\>500 milligram per deciliter (mg/dL).\n* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\]) greater than 3× upper limit of normal (ULN).'}, 'identificationModule': {'nctId': 'NCT04823208', 'briefTitle': 'A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '17609'}, 'secondaryIdInfos': [{'id': 'J1I-JE-GZBC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3437943', 'description': 'LY3437943 administered subcutaneously (SC)', 'interventionNames': ['Drug: LY3437943']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3437943', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3437943']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0853', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OCROM Clinic'}, {'zip': '192-0071', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'P-one clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '162-0053', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Clinical Research Hospital Tokyo'}, {'zip': '232-0064', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama Minoru Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], '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'}}}}