Hypoparathyroidism
Conditions
Keywords
Hypoparathyroid, Hypopara, Thyroid, MBX 2109
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.
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.
Interventions
DRUG400 µg of MBX 2109 once-weekly by subcutaneous injection
Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly
DRUG200-1600 µg of MBX 2109 once-weekly by subcutaneous injection
Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002. The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections.
Sponsors
MBX Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism. | 104 weeks | Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). |
Countries
Argentina, Turkey (Türkiye), United States
Outcome results
None listed