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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525326-37-00 | EU Trial (CTIS) Number |
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The purpose of this study is to investigate the efficacy and safety of canvuparatide administered as a once-weekly (QW) treatment to adult study participants with hypoparathyroidism (HypoPT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canvuparatide | Active Comparator | Canvuparatide is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of canvuparatide via a manual SC injection. Dosing is once weekly. |
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| Placebo | Placebo Comparator | Placebo is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of placebo via a manual SC injection. Dosing is once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canvuparatide | Drug | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of pooled weekly doses of canvuparatide on the proportion of responder patients at week 26. | Responder status is defined as a study participant who meets the following composite criteria:
| 26 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salomon Azoulay, MD | Contact | 844-877-4473 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBX Biosciences Investigational Site | Recruiting | Homestead | Florida | 33030 | United States | |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo | Other | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
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| MBX Biosciences Investigational Site |
| Recruiting |
| Shavano Park |
| Texas |
| 78231 |
| United States |