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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPJ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron + Carbamazepine | Experimental | Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron | PK: AUC (0-∞) of Orforglipron | Predose up to Day 18 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron | PK: AUC (0-tlast) of Orforglipron | Predose up to Day 18 |
| PK: Maximum Observed Concentration (Cmax) of Orforglipron | PK: Cmax of Orforglipron | Predose up to Day 18 |
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Inclusion Criteria:
Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).
Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
Have a hemoglobin level of
Have venous access sufficient to allow for blood sampling.
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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services | San Antonio | Texas | 78209 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2026 | |
| Reset | May 26, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 26, 2026 | |||
| Jun 19, 2026 |
| ID | Term |
|---|---|
| C000729680 | orforglipron |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | Administered orally |
|