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| ID | Type | Description | Link |
|---|---|---|---|
| I8P-MC-OXAB | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study.
This study is for research purposes only and is not intended to treat any medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3305677 | Experimental | Escalating doses of LY3305677 administered by subcutaneous (SC) injection |
|
| Placebo | Placebo Comparator | Saline solution administered by SC injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3305677 | Drug | Administered SC |
| |
| Placebo |
| 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 115 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677 | PK: Cmax of LY3305677 | Days 1 and 29: Predose through 168 hours post dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677 |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Leeds | West Yorkshire | LS2 9LH |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| Drug |
Administered SC |
|
PK: AUC of LY3305677
| Days 1 and 29: Predose through 168 hours post dose |
| United Kingdom |