Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-29 @ 9:13 AM
Study NCT ID:
NCT06945406
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part A is Double-Blinded, Parts B and C are Open-Label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Parts A and C are sequential: Part B is crossover'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline to Study Completion (Up to 47 Weeks)', 'description': 'A summary of SAEs and AEs 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 LY4057996', 'timeFrame': 'Baseline to Study Completion (Up to 47 Weeks)', 'description': 'PK: AUC of LY4057996'}, {'measure': 'PK: Maximum Concentration (Cmax) of LY4057996', 'timeFrame': 'Baseline to Study Completion (Up to 47 Weeks)', 'description': 'PK: Cmax of LY4057996'}, {'measure': 'Pharmacodynamic (PD): Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline to Study Completion (Up to 47 Weeks)', 'description': 'PD: Change from Baseline in Fasting Glucose'}, {'measure': 'PD: AUC of Glucose Infusion Rate (GIR)', 'timeFrame': 'Baseline Up to 10 weeks', 'description': 'PD: AUC of GIR'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/599655', 'label': 'A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A for Healthy Participants:\n\n* Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment\n\nPart A for Type 2 Diabetes (T2DM) Participants:\n\n* Are participants with T2DM diagnosed greater than 1 year before enrollment,\n* On basal insulin therapy, insulin glargine, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)\n* Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening\n\nPart B\n\n* Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening\n* HbA1c 6% to 8.5% inclusive at screening\n\nPart C\n\n* Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening\n* HbA1c 6 to 8% inclusive at screening\n\nAll Parts\n\n* Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)\n* No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants\n\nExclusion Criteria:\n\n* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening\n* Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening\n\nAll Parts\n\n* Cardiovascular: no significant history of cardiovascular disease (CVD)\n* Gastrointestinal: have gastroparesis or have undergone gastric surgery\n* Hepatic: have acute or chronic hepatitis'}, 'identificationModule': {'nctId': 'NCT06945406', 'acronym': 'YKAA', 'briefTitle': 'A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '27329'}, 'secondaryIdInfos': [{'id': '2024-519151-28-00', 'type': 'CTIS'}, {'id': 'J6B-MC-YKAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4057996 Part A (Cohorts A1-A5)', 'description': 'LY4057996 administered subcutaneously (SC) and/or intravenously (IV)', 'interventionNames': ['Drug: LY4057996 SC', 'Drug: LY4057996 IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A (Cohort A1-A5)', 'description': 'Placebo administered SC and/or IV', 'interventionNames': ['Drug: Placebo SC', 'Drug: Placebo IV']}, {'type': 'EXPERIMENTAL', 'label': 'LY4057996 Part B', 'description': 'LY4057996 administered SC', 'interventionNames': ['Drug: LY4057996 SC']}, {'type': 'EXPERIMENTAL', 'label': 'LY4057996 Part C', 'description': 'LY4057996 and interventions of pre-study basal insulin and Lispro administered SC', 'interventionNames': ['Drug: LY4057996 SC', 'Drug: Lispro SC', 'Drug: Pre-study basal insulin SC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Degludec Part A (Cohort A2-A5)', 'description': 'Degludec administered SC and/or IV', 'interventionNames': ['Drug: Degludec SC', 'Drug: Degludec IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Degludec Part B', 'description': 'Degludec administered SC', 'interventionNames': ['Drug: Degludec SC']}], 'interventions': [{'name': 'LY4057996 SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4057996 Part A (Cohorts A1-A5)', 'LY4057996 Part B', 'LY4057996 Part C']}, {'name': 'LY4057996 IV', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['LY4057996 Part A (Cohorts A1-A5)']}, {'name': 'Placebo SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo Part A (Cohort A1-A5)']}, {'name': 'Placebo IV', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Placebo Part A (Cohort A1-A5)']}, {'name': 'Degludec SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Degludec Part A (Cohort A2-A5)', 'Degludec Part B']}, {'name': 'Lispro SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4057996 Part C']}, {'name': 'Degludec IV', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Degludec Part A (Cohort A2-A5)']}, {'name': 'Pre-study basal insulin SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4057996 Part C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'role': 'CONTACT', 'phone': '+49 (0) 2131 4018 180'}, {'name': 'Oliver Klein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Profil Institut für Stoffwechselforschung', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], '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'}}}}