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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01604408 | A Study in Older Participants Who Have Fallen and Have Muscle Weakness | PHASE2 | COMPLETED | 201 | — | — | May 1, 2012 | Dec 1, 2013 | Apr 25, 2018 | 22 | United States, Argentina +4 |
Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
| Arm | Type | Description |
|---|---|---|
| LY2495655 | EXPERIMENTAL | Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks. |
| Name | Type | Description |
|---|---|---|
| LY2495655 | BIOLOGICAL | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Sustained at least 1 fall within 1 calendar year before study screening. * Requires ≥12 seconds to perform a repeated chair stands test or is unable to complete this test at screening. * Hand grip strength is ≤37 kilograms (kg) for men (81.4 pounds) or ≤21 kg for women (46.2 p...