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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | placebo |
|
| Group 2 | Experimental | REGN1033 (SAR391786) |
|
| Group 3 | Placebo Comparator | placebo + exercise regimen |
|
| Group 4 | Experimental | REGN1033 (SAR391786) + exercise regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033 (SAR391786) | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total lean mass | The primary endpoint is percent change in total lean mass at week 12 (day 85) | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs | Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study) | day 1 to day 141 |
| Appendicular lean mass by DXA | Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville | Florida | United States | ||||
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|
| At week 12 |
| Orlando |
| Florida |
| United States |
| Boston | Massachusetts | United States |
| St Louis | Missouri | United States |
| Athens | Ohio | United States |