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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-JE-GZPM | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron | Experimental | Participants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State) | PK: Steady-state AUC of Orforglipron (Fasted State) | Week 3 Through Week 16 |
| PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State) | PK: Steady-state Cmax of Orforglipron (Fasted State) | Week 3 Through Week 16 |
| PK: Steady-state AUC of Orforglipron (Fed State) | PK: Steady-state AUC of Orforglipron (Fed State) | Week 3 Through Week 16 |
| PK: Steady-state Cmax of Orforglipron (Fed State) | PK: Steady-state Cmax of Orforglipron (Fed State) | Week 3 Through Week 16 |
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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 |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan | ||
| Sumida Hospital |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| Sumida-ku |
| Tokyo |
| 130-0004 |
| Japan |
| Hakata Clinic | Fukuoka | 812-0025 | Japan |