Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465108
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-13
Brief Title:
Safety Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism
Sponsor:
MBX Biosciences
Organization:
MBX Biosciences
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 2 Trial to Evaluate the Safety Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism Avail Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism
Detailed Description:
This study is to investigate the safety pharmacokinetics and efficacy of MBX 2109 administered once weekly to patients with hypoparathyroidism Given MBX 2109 is intended as a PTH replacement hormone to demonstrate that MBX 2109 can maintain serum calcium within a normal range without the need for active vitamin D and therapeutic calcium supplements
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