Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2541546 · 3 trials · 2 indications
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
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 Q4W + Placebo | EXPERIMENTAL | LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| 180 mg LY2541546 Q2W | EXPERIMENTAL | LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q2W | EXPERIMENTAL | LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q12W + Placebo | EXPERIMENTAL | LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| Placebo Comparator Q2W | PLACEBO_COMPARATOR | Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 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 | DRUG | Administered subcutaneously |
| Placebo | DRUG | Administered subcutaneously |
| LY2541546 - SC | DRUG | Administered SC |
| LY2541546 - IV | DRUG | Administered IV |
| Placebo - SC | DRUG | Administered SC |
| Placebo - IV | DRUG | Administered IV |
Inclusion Criteria: * Ambulatory, postmenopausal women, inclusive. * Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter \[g/cm\^2\]) for the lumbar spine of between -3.5 and -2.0, inclusive. * Without language barrier, reliable, and w...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
LY2541546 is an investigational small molecule being studied for osteoporosis in postmenopausal women with low bone mineral density and for use in healthy postmenopausal women. It is being developed by Eli Lilly and Company and is currently in clinical development, with completed Phase 1 and Phase 2 trials.
LY2541546 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is in clinical development for osteoporosis and related bone health conditions.
LY2541546 is in Phase 1 and Phase 2 clinical development. It has completed two Phase 1 trials in healthy postmenopausal women and one Phase 2 trial in women with low bone mineral density. The drug is investigational and not yet approved by regulatory authorities.
LY2541546 has been studied in three completed clinical trials. NCT01144377 was a Phase 2 trial in 154 women with osteoporosis in the United States, Denmark, Estonia, Japan, and Lithuania. NCT01742078 and NCT01742091 were Phase 1 trials in healthy postmenopausal women in the United States, with 60 and 59 participants respectively.
LY2541546 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development. The trials completed include Phase 1 and Phase 2 studies, but no approval status has been granted, and the drug is still considered investigational.
LY2541546 is an investigational small molecule drug being developed by Eli Lilly and Company for osteoporosis and bone health. It has been studied in postmenopausal women, including those with low bone mineral density. Clinical trials have been completed, but the drug is not yet approved.