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Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism

StatusActive, Not Recruiting
PhasePhase 2
Started2024-10-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later May 27, 2027 → May 2028
See other at-risk trials from MBX Biosciences

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-10-06
Primary completion pushed: 2027-05-27 → 2028-05
Completion pushed: 2027-05-27 → 2028-05
Eligibility criteria+24 characters
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 fo [...] de by the study restrictions, study visits, and procedures. 5. In the opinion of the investigator, must be able to successf [...]
Study sitesdetails revised at 3 of 23 sites
2025-10-24
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 48→confirmed 60
Study sites22→23
2024-11-11
Study Status, Contacts/Locations v19
Study sites21→22
2024-11-07
Study Status, Contacts/Locations v18
Study sites20→21
2024-11-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v17
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-31
Study sitesdetails revised at 20 of 20 sites
Show 15 earlier versions
2024-10-31
Study Status, Contacts/Locations v16
Study sites19→20
2024-10-29
Study Status, Contacts/Locations v15
Study sites18→19
2024-10-25
Study Status, Contacts/Locations v14
Study sites17→18
2024-10-22
Study Status, Contacts/Locations v13
Study sites16→17
2024-10-08
Study Status, Contacts/Locations v12
Study sites15→16
2024-10-07
Study Status, Contacts/Locations v11
Study sites14→15
2024-09-27
Study Status, Contacts/Locations v10
Study sites13→14
2024-09-05
Study Status, Contacts/Locations v9
Study sites12→13
2024-08-29
Study Status, Contacts/Locations v8
Study sites11→12
2024-08-28
Study Status, Contacts/Locations v7
Study sites10→11
2024-08-22
Study Status, Arms and Interventions, Contacts/Locations v6
Study sites9→10
Study arms3→2
Interventions400 µg of MBX 2109 once-weekly by subcutaneous injection (Drug), 600 µg of MBX 2109 once-weekly by subcutaneous injection (Drug), 800 µg of…→200-1600 µg of MBX 2109 once-weekly by subcutaneous injection (Drug), 400 µg of MBX 2109 once-weekly by subcutaneous injection (Drug)
2024-08-21
Study Status, Contacts/Locations v5
Study sites8→9
2024-08-13
Study Status, Contacts/Locations v4
Study sites6→8
2024-08-05
Study Status, Contacts/Locations v3
Study sites5→6
2024-07-31
Study Status, Study Description v2
Study description+9 characters
This study is to investigate the long-term safety and tolerability of MBX 2109 administered QWonce weekly to patients with hypoparathyroidism. Additionally, the abil [...]
2024-07-30
Original filing
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.
Trial Details
NCT Number NCT06531941
Lead Sponsor MBX Biosciences
Conditions Hypoparathyroidism
Enrollment 60 participants
Start Date 2024-10-31
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-10-07