Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 167 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | Two (2) women in each of cohorts 1 and 4, and two (2) men in cohort 2 will receive placebo every 2 weeks for a total of 6 doses. Two (2) women in each of cohorts 3 and 5, and two (2) men in cohort 6 will receive placebo every 4 weeks for a total of 3 doses. Six (6) women in cohort 7 will receive placebo every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of placebo; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment. |
| B | ACTIVE_COMPARATOR | Six (6) women in each of cohorts 1 and 4, and six (6) men in cohort 2 will receive AMG 167 every 2 weeks for a total of 6 doses. Six (6) women in each of cohorts 3 and 5, and six (6) men in cohort 6 will receive AMG 167 every 4 weeks for a total of 3 doses. Eighteen (18) women in cohort 7 will receive AMG 167 every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of AMG 167; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin. |
| AMG 167 | DRUG | Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin. |
Inclusion Criteria: * Low bone mineral density as determined at the time of screening \[as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4), or total evaluable vertebrae (if fewer than L1-L4); or femoral neck between -1.0 and -2.5, exclusive\] * 25-hydroxyvitamin D ≥ 20 ng...
AMG 167 is an investigational small molecule being developed for osteopenia, a condition of low bone mineral density. It is being studied in healthy men and postmenopausal women with low bone mineral density. The drug is in Phase 1 clinical development and is not yet approved.
AMG 167 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical trials for osteopenia.
AMG 167 is in Phase 1 clinical development. It has completed two Phase 1 trials, with a total enrollment of 143 participants. The drug is investigational and has not been approved for any use.
AMG 167 has completed two Phase 1 trials: NCT00902356, a first-in-human study in healthy men and postmenopausal women, and NCT01101048, an ascending multiple dose study in healthy men and postmenopausal women with low bone mineral density. Both trials were placebo-controlled and double-blind.
No alternative names for AMG 167 have been disclosed. The drug is identified solely by its code name AMG 167 in clinical trials and development records.