Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823012
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-03-28
Brief Title:
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Sponsor:
Xeris Pharmaceuticals
Organization:
Xeris Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Multicenter Non-Randomized Open-Label Single Arm Self-controlled Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized open-label single arm self-controlled study of XP-8121 levothyroxine sodium to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 levothyroxine sodium in patients with hypothyroidism and to assess the safety and tolerability of XP-8121levothyroxine sodium after once weekly subcutaneous injections This study includes the following periods Screening Titration Period and Maintenance Period The study will conclude with an End of Maintenance Visit or Early Termination ET Visit
Detailed Description:
This is a non-randomized open-label single arm self-controlled study of XP-8121 levothyroxine sodium to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 levothyroxine sodium in patients with hypothyroidism and to assess the safety and tolerability of XP-8121 levothyroxine sodium after once weekly subcutaneous injections This study includes the following periods Screening Titration Period 2 to 8 weeks and Maintenance Period 4 weeks A pharmacokinetic substudy will be conducted for a subset of patients during the Maintenance Period The study will conclude with an End of Maintenance Visit or Early Termination ET Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None