Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577935
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Group Dose-Finding Study to Evaluate the Safety Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEMIS
Brief Summary:
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density BMD in postmenopausal women with low bone mass
Detailed Description:
This Phase 2 dose-finding study will evaluate the safety tolerability and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine total hip or femoral neck and no prior history of fragility fractures
This study includes a 12 month blinded treatment phase where participants will be randomized 1111111 to receive double-blind dosing regimens of AGA2118 or placebo At Month 12 participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen receive a new dosing regimen or discontinue treatment and be actively surveilled throughout Months 12 to 24
This study includes a 12 month blinded treatment phase where participants will be randomized 1111111 to receive double-blind dosing regimens of AGA2118 or placebo At Month 12 participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen receive a new dosing regimen or discontinue treatment and be actively surveilled throughout Months 12 to 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None