A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism

Part of paid clinical trials in Homestead, Florida.

Sponsor
MBX Biosciences
Study ID
NCT07699471
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hypoparathyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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).

Key Dates

First listed
Jul 13, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Canvuparatide
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

To evaluate the effect of pooled weekly doses of canvuparatide on the proportion of responder patients at week 26. [ Time Frame: 26 Weeks ]

Central Contacts

  • Salomon Azoulay, MD
    844-877-4473

Locations (2)

FacilityCityStateZIPSite coordinators
MBX Biosciences Investigational SiteHomesteadFlorida33030-
MBX Biosciences Investigational SiteShavano ParkTexas78231-

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MBX Biosciences Investigational Site· Homestead, FLMBX Biosciences Investigational Site· Shavano Park, TX

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