Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152042
Status:
SUSPENDED
Last Update Posted:
2024-06-18
First Post:
2023-11-10
Brief Title:
Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus
Sponsor:
Biomea Fusion Inc
Organization:
Biomea Fusion Inc
Study Overview
Official Title:
Phase 2 Randomized Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
Status:
SUSPENDED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Clinical Hold by the US FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus
Detailed Description:
Study COVALENT-112 is a 52-week Phase 2 trial designed to examine beta-cell function insulin sensitivity and both glucose and lipid metabolism in participants with T1D treated with BMF-219 BMF-219 is an orally bioavailable covalent small-molecule menin inhibitor
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