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-2H1002.
Brief Title
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
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 calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-877-4473
Central Contact Email
MBX2109.Clinicaltrials@mbxbio.com
Central Contact Role
Contact
Central Contact Phone
844-877-4473
Central Contact Email
MBX2109.Clinicaltrials@mbxbio.com
Completion Date
Completion Date Type
Estimated
Conditions
Hypoparathyroidism
Eligibility Criteria
Key Inclusion Criteria:
1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
Screening visit:
1. Postsurgical chronic hypoparathyroidism
2. Idiopathic hypoparathyroidism
3. Autoimmune hypoparathyroidism
4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
Screening visit:
1. Postsurgical chronic hypoparathyroidism
2. Idiopathic hypoparathyroidism
3. Autoimmune hypoparathyroidism
4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
Inclusion Criteria
Key Inclusion Criteria:
1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
Screening visit:
1. Postsurgical chronic hypoparathyroidism
2. Idiopathic hypoparathyroidism
3. Autoimmune hypoparathyroidism
4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
Screening visit:
1. Postsurgical chronic hypoparathyroidism
2. Idiopathic hypoparathyroidism
3. Autoimmune hypoparathyroidism
4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
Gender
All
Gender Based
false
Keywords
Hypoparathyroid
Hypopara
Thyroid
MBX 2109
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT06531941
Org Class
Industry
Org Full Name
MBX Biosciences
Org Study Id
MBX-2H1004
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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)
Primary Outcomes
Outcome Description
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Outcome Measure
To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
Outcome Time Frame
104 weeks
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Vafa Tabatabaie
Investigator Email
vtabatab@montefiore.org
Investigator Phone
718-920-7923