Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
NCT ID: NCT06531941
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-10-31
2027-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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400 µg once-weekly by subcutaneous injection
400 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
200-1600 µg once-weekly by subcutaneous injection
200-1600 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.
Interventions
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400 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
200-1600 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.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
100 Years
ALL
No
Sponsors
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MBX Biosciences
INDUSTRY
Responsible Party
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Locations
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MBX Biosciences Investigational Site
Miami, Florida, United States
MBX Biosciences Investigational Site
Macon, Georgia, United States
MBX Biosciences Investigational Site
Jackson, Mississippi, United States
MBX Biosciences Investigational Site
St Louis, Missouri, United States
MBX Biosciences Investigational Site
Las Vegas, Nevada, United States
MBX Biosciences Investigational Site
Reno, Nevada, United States
MBX Biosciences Investigational Site
Albany, New York, United States
MBX Biosciences Investigational Site
New York, New York, United States
MBX Biosciences Investigational Site
The Bronx, New York, United States
MBX Biosciences Investigational Site
Columbus, Ohio, United States
MBX Biosciences Investigational Site
Dallas, Texas, United States
MBX Biosciences Investigational Site
El Paso, Texas, United States
MBX Biosciences Investigational Site
Fort Worth, Texas, United States
MBX Biosciences Investigational Site
Round Rock, Texas, United States
MBX Biosciences Investigational Site
San Antonio, Texas, United States
MBX Biosciences Investigational Site
Weslaco, Texas, United States
MBX Biosciences Investigational Site
Madison, Wisconsin, United States
MBX Biosciences Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
MBX Biosciences Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
MBX Biosciences Investigational Site
Córdoba, Río Cuarto, Argentina
MBX Biosciences Investigational Site
Córdoba, , Argentina
MBX Biosciences Investigational Site
San Miguel de Tucumán, , Argentina
MBX Biosciences Investigational Site
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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MBX-2H1004
Identifier Type: -
Identifier Source: org_study_id
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