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| ID | Type | Description | Link |
|---|---|---|---|
| J6H-MC-KXAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), and how it's processed in the body.
The study will last approximately 25 weeks, excluding a screening period with an optional extension to approximately 49 weeks for qualifying participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3981314 Part A | Experimental | Single-ascending doses of LY3981314 administered subcutaneously (SC) |
|
| LY3981314 Part B | Experimental | Single dose of LY3981314 administered SC |
|
| Placebo Part A | Placebo Comparator | Placebo administered SC |
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| Placebo Part B | Placebo Comparator | Placebo administered SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3981314 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3981314 | PK: AUC of LY3981314 | Baseline Up to Approximately Week 25 |
| PK: Maximum Concentration (Cmax) of LY3981314 |
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Inclusion Criteria:
Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG)
Individuals assigned male at birth who agree to follow contraceptive requirements, or individuals assigned female at birth and not of childbearing potential
Have venous access sufficient to allow for blood sampling
Have a body weight within 45 to 145 kilograms (kg) and body mass index within the range of 18.5 to 35 kilogram per square meter (kg/m²) (inclusive)
For Part B:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States |
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| Placebo |
| Drug |
Administered SC |
|
PK: Cmax of LY3981314
| Baseline up to Approximately Week 25 |