An Extension Study 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-2H1002 Study (Avail-Ext)
Status: Active_not_recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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-2H1002.
Participation Requirements• 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.
MBX Biosciences Investigational Site
Miami
MBX Biosciences Investigational Site
Macon
MBX Biosciences Investigational Site
St Louis
MBX Biosciences Investigational Site
Jackson
MBX Biosciences Investigational Site
Las Vegas
MBX Biosciences Investigational Site
Reno
MBX Biosciences Investigational Site
Albany
MBX Biosciences Investigational Site
New York
MBX Biosciences Investigational Site
The Bronx
MBX Biosciences Investigational Site
Columbus
MBX Biosciences Investigational Site
Dallas
MBX Biosciences Investigational Site
El Paso
MBX Biosciences Investigational Site
Fort Worth
MBX Biosciences Investigational Site
Round Rock
MBX Biosciences Investigational Site
San Antonio
MBX Biosciences Investigational Site
Weslaco
MBX Biosciences Investigational Site
Madison
MBX Biosciences Investigational Site
Ciudad Autonoma De Buenos Aires
MBX Biosciences Investigational Site
Ciudad Autonoma De Buenos Aires
MBX Biosciences Investigational Site
Córdoba
MBX Biosciences Investigational Site
Córdoba
MBX Biosciences Investigational Site
San Miguel De Tucumán
MBX Biosciences Investigational Site
Samsun
Start Date: 2024-10-31
Completion Date: 2027-05-27
Target number of participants: 60
Experimental: 400 µg once-weekly by subcutaneous injection
Experimental: 200-1600 µg once-weekly by subcutaneous injection