Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01963598 | Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia | PHASE2 | COMPLETED | 253 | — | — | Nov 1, 2013 | Feb 1, 2015 | Mar 28, 2016 | 43 | United States, France +2 |
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).
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| REGN1033 (SAR391786) | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: 1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal) 2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions 3. Ability to follow a walking program 4. ...