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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Dosing regimen 1 |
|
| Group 2 | Experimental | Dosing regimen 2 |
|
| Group 3 | Experimental | Dosing regimen 3 |
|
| Group 4 | Experimental | Dosing regimen 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033 (SAR391786) | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total lean body mass | The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85). | day 1 to day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs | TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141). | day 1 to day 141 |
| Change in appendicular lean mass | Changes from baseline (day 1) in appendicular lean mass by DEXA |
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Inclusion Criteria:
Exclusion Criteria:
The information listed above 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 |
|---|---|---|---|---|---|---|
| Anniston | Alabama | United States | ||||
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| Drug |
|
| day 1 to day 141 |
| Change in maximal leg press strength (1-RM) | Change from baseline in maximal leg press strength (1-repetition max) | day 1 to day 141 |
| Change in maximal chest press strength (1-RM) | Change from baseline in maximal chest press strength (1-repetition max) | day 1 to day 141 |
| Change in 4M gait speed | Change from baseline in 4-meter (4M) gait speed | day 1 to day 141 |
| Change in SPPB subscores | Change from baseline in SPPB (Short Physical Performance Battery) subscores | day 1 to day 141 |
| Change in distance walked in the 6MWT | Change from baseline in distance walked in the 6MWT (6-Minute Walk Test) | day 1 to day 141 |
| Change in regional and total fat mass by DEXA | Change from baseline in regional and total fat mass by DEXA | day 1 to day 141 |
| Change in hand grip strength by handheld dynamometer | Change from baseline in hand grip strength by handheld dynamometer | day 1 to day 141 |
| Change in unloaded and loaded stair climb power | Change from baseline in unloaded and loaded stair climb power | day 1 to day 141 |
| Phoenix |
| Arizona |
| United States |
| El Cajon | California | United States |
| Garden Grove | California | United States |
| Laguna Hills | California | United States |
| San Francisco | California | United States |
| Walnut Creek | California | United States |
| Aurora | Colorado | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | United States |
| Jupiter | Florida | United States |
| Orlando | Florida | United States |
| South Miami | Florida | United States |
| Chicago | Illinois | United States |
| Baton Rouge | Louisiana | United States |
| College Park | Maryland | United States |
| Elkridge | Maryland | United States |
| Boston | Massachusetts | United States |
| Edina | Minnesota | United States |
| Omaha | Nebraska | United States |
| Albuquerque | New Mexico | United States |
| High Point | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Athens | Ohio | United States |
| Columbus | Ohio | United States |
| Duncansville | Pennsylvania | United States |
| Spartanburg | South Carolina | United States |
| Dallas | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| West Jordan | Utah | United States |
| Richmond | Virginia | United States |
| Limoges | France |
| Montpellier | France |
| Saint-Etienne | France |
| Toulouse | France |
| Amsterdam | Netherlands |
| Leeuwarden | Netherlands |
| Noord-Brabant | Netherlands |
| Albacete | Spain |
| L'Hospitalet de Llobregat | Spain |
| Madrid | Spain |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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