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| ID | Type | Description | Link |
|---|---|---|---|
| J1R-MC-GZFB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3457263 (Alone) | Experimental | LY3457263 administered subcutaneously (SC). |
|
| Placebo (Alone) | Placebo Comparator | Placebo administered SC. |
|
| LY3457263 + Dulaglutide | Experimental | LY3457263 in combination with dulaglutide administered SC. |
|
| Placebo + Dulaglutide | Experimental | Placebo in combination with dulaglutide administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3457263 | 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, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Predose up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263 | PK: AUC of LY3457263 | Pre-dose on Day 1 up to 85 days post-dose |
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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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| CenExel ACT |
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| Placebo |
| Drug |
Administered SC. |
|
| Dulaglutide | Drug | Administered SC. |
|
|
| Anaheim |
| California |
| 92801 |
| United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 2012 | United States |
| CenExel-HRI | Berlin | New Jersey | 08009 | United States |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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