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| ID | Type | Description | Link |
|---|---|---|---|
| J4Z-MC-GIDG | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimagrumab Dose 1 Reference Material | Experimental | Participants will receive a single dose of bimagrumab subcutaneously (SC) |
|
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration) | Experimental | Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC |
|
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation) | Experimental | Participants will receive a single dose of bimagrumab with tirzepatide SC |
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| Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) | Experimental | Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks |
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| Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation) | Experimental | Participants will receive bimagrumab with tirzepatide SC for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimagrumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material | Predose through Week 13 | |
| PK: Cmax of Bimagrumab Reference Material | Predose through Week 13 | |
| PK: Cmax of Bimagrumab Coadministered with Tirzepatide | Predose through Week 13 | |
| PK: Cmax of Tirzepatide Coadministered with Bimagrumab | Predose through Week 16 | |
| PK: Cmax of Bimagrumab Coformulated with Tirzepatide | Predose through Week 16 | |
| PK: Cmax of Tirzepatide Coformulated with Bimagrumab | Predose through Week 16 | |
| PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material | Predose through Week 13 | |
| PK: AUC(0-∞) of Bimagrumab Reference Material | Predose through Week 13 | |
| PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide | Predose through Week 13 | |
| PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab | Predose 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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000596367 | bimagrumab |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Tirzepatide | Drug | Administered SC |
|
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| Bimagrumab + Tirzepatide Coformulation | Drug | Administered SC |
|
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| PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide |
| Predose through Week 16 |
| PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab | Predose through Week 16 |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |