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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01742091 | A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women | PHASE1 | COMPLETED | 59 | — | — | Sep 1, 2009 | Mar 1, 2010 | Jul 18, 2018 | 5 | United States |
| NCT01742078 | A Study of LY2541546 in Healthy Postmenopausal Women | PHASE1 | COMPLETED | 60 | — | — | Jun 1, 2008 | Jun 1, 2010 | Jan 23, 2019 | 2 | United States |
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * is considered significant by the investigator for any other reason
| Arm | Type | Description |
|---|---|---|
| 180 mg LY2541546 SC Q4W | EXPERIMENTAL | 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. |
| 270 mg LY2541546 SC Q2W | EXPERIMENTAL | 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. |
| 270 mg LY2541546 SC Q4W | EXPERIMENTAL | 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. |
| 540 mg LY2541546 IV Q4W | EXPERIMENTAL | 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. |
| 750 mg LY2541546 IV Q2W | EXPERIMENTAL | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| Placebo Q2W | PLACEBO_COMPARATOR | Placebo administered IV or SC once every 2 weeks for 8 weeks. |
| 7.5 mg LY2541546 - IV | EXPERIMENTAL | Single dose of 7.5 mg LY2541546 administered intravenously (IV) |
| 25 mg LY2541546 - IV | EXPERIMENTAL | Single dose of 25 mg LY2541546 administered IV |
| 75 mg LY2541546 - IV | EXPERIMENTAL | Single dose of 75 mg LY2541546 administered IV |
| 225 mg LY2541546 - IV | EXPERIMENTAL | Single dose of 225 mg LY2541546 administered IV |
| 750 mg LY2541546 - IV | EXPERIMENTAL | Single dose of 750 mg LY2541546 administered IV |
| 150 mg LY2541546 - SC | EXPERIMENTAL | Single dose of 150 mg LY2541546 administered subcutaneous (SC) |
| Placebo | PLACEBO_COMPARATOR | Single dose of placebo administered IV or SC |
| 225 mg LY2541546 - IV, OL | EXPERIMENTAL | Single dose of 225 mg LY2541546 administered IV, open label (OL) |
| 750 mg LY2541546 - IV, OL | EXPERIMENTAL | Single dose of 750 mg LY2541546 administered IV, OL |
| Name | Type | Description |
|---|---|---|
| LY2541546 - SC | DRUG | Administered SC |
| LY2541546 - IV | DRUG | Administered IV |
| Placebo - SC | DRUG | Administered SC |
| Placebo - IV | DRUG | Administered IV |
| Placebo | DRUG | Administered IV or SC |
Inclusion Criteria: * Healthy postmenopausal females, as determined by medical history and physical examination * Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive * Acceptable clinical laboratory test results, blood pressure and heart rate * H...