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MBX 2109 Extension Study in Hypoparathyroidism (Avail-Ext)
NCT06531941Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2024
- Primary completion
- May 2028
- Countries
- 3
- Sponsor
- MBX Biosciences, Inc.
- Modality
- Peptides
- Drugs
- canvuparatide
- Conditions
- hypoparathyroidism
01
Overview
Phase 2, open-label trial of canvuparatide in hypoparathyroidism (2 arms), sponsored by MBX Biosciences, Inc. Primary endpoint: Long-term safety and tolerability of weekly MBX 2109 at 104 weeks. Started Oct 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
400 µg once-weekly by subcutaneous injection
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
Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue on the same dose they were receiving at the Week 11 Visit
03
Who it enrols
Adults with hypoparathyroidism (postsurgical chronic, idiopathic, or autoimmune) for at least 26 weeks who completed the Week 12 Visit in the MBX-2H1002 Study.
04
Endpoints
Primary
Long-term safety and tolerability of weekly MBX 2109
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