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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519151-28-00 | EU Trial (CTIS) Number | ||
| J6B-MC-YKAA | Other Identifier | Eli Lilly and Company |
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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4057996 Part A (Cohorts A1-A5) | Experimental | LY4057996 administered subcutaneously (SC) and/or intravenously (IV) |
|
| Placebo Part A (Cohort A1-A5) | Placebo Comparator | Placebo administered SC and/or IV |
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| LY4057996 Part B | Experimental | LY4057996 administered SC |
|
| LY4057996 Part C | Experimental | LY4057996 and interventions of pre-study basal insulin and Lispro administered SC |
|
| Degludec Part A (Cohort A2-A5) | Active Comparator | Degludec administered SC and/or IV |
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| Degludec Part B | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4057996 SC | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to Study Completion (Up to 47 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996 | PK: AUC of LY4057996 | Baseline to Study Completion (Up to 47 Weeks) |
| PK: Maximum Concentration (Cmax) of LY4057996 |
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Inclusion Criteria:
Part A for Healthy Participants:
Part A for Type 2 Diabetes (T2DM) Participants:
Part B
Part C
All Parts
Exclusion Criteria:
All Parts
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Recruiting | Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes | View source |
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Parts A and C are sequential: Parts B and C are crossover
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Part A is Double-Blinded, Parts B and C are Open-Label
Degludec administered SC |
|
| LY4057996 IV | Drug | Administered IV |
|
| Placebo SC | Drug | Administered SC |
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| Placebo IV | Drug | Administered IV |
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| Degludec SC | Drug | Administered SC |
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| Lispro SC | Drug | Administered SC |
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| Degludec IV | Drug | Administered IV |
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| Pre-study basal insulin SC | Drug | Administered SC |
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PK: Cmax of LY4057996
| Baseline to Study Completion (Up to 47 Weeks) |
| Pharmacodynamic (PD): Change from Baseline in Fasting Glucose | PD: Change from Baseline in Fasting Glucose | Baseline to Study Completion (Up to 47 Weeks) |
| PD: AUC of Glucose Infusion Rate (GIR) | PD: AUC of GIR | Baseline Up to 10 weeks |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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