Status:
ACTIVE_NOT_RECRUITING
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
Lead Sponsor:
MBX Biosciences
Conditions:
Hypoparathyroidism
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H10...
Detailed Description
This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum cal...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Must have completed the Week 12 Visit in MBX-2H1002 Study.
- Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
- Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
- Screening visit:
- Postsurgical chronic hypoparathyroidism
- Idiopathic hypoparathyroidism
- Autoimmune hypoparathyroidism
- Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
- In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
Exclusion
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06531941
Start Date
October 31 2024
End Date
May 27 2027
Last Update
October 28 2025
Active Locations (23)
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1
MBX Biosciences Investigational Site
Miami, Florida, United States, 33033
2
MBX Biosciences Investigational Site
Macon, Georgia, United States, 31210
3
MBX Biosciences Investigational Site
Jackson, Mississippi, United States, 39202
4
MBX Biosciences Investigational Site
St Louis, Missouri, United States, 63110