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| ID | Type | Description | Link |
|---|---|---|---|
| I9S-MC-BTAA | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3361237 - Subcutaneous (SC) | Experimental | LY3361237 administered SC |
|
| Placebo - SC | Placebo Comparator | Placebo administered SC |
|
| LY3361237 - Intravenous (IV) | Experimental | LY3361237 administered IV |
|
| Placebo - IV | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3361237 - SC | Drug | LY3361237 administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 | PK: Cmax of LY3361237 | Predose through Week 12 |
| PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237 | PK: AUC of LY3361237 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States |
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| LY3361237 - IV |
| Drug |
LY3361237 administered IV |
|
| Placebo - SC | Drug | Placebo administered SC |
|
| Placebo - IV | Drug | Placebo administered IV |
|
| Predose through Week 12 |