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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
• 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.
• 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.
MBX Biosciences Investigational Site
Homestead, Florida, United States
RECRUITINGMBX Biosciences Investigational Site
Metairie, Louisiana, United States
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: * Independence from active vitamin D * Independence from therapeutic doses of calcium (standing elemental calcium dose of ≤ 600 mg/day) * 2 consecutive albumin-adjusted serum calcium results in the normal range (8.3-10.6 mg/dL) (2.07-2.64 mmol/L) * No increase in study drug
Time frame: 26 Weeks
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MBX Biosciences Investigational Site
Las Vegas, Nevada, United States
RECRUITINGMBX Biosciences Investigational Site
Reno, Nevada, United States
RECRUITINGMBX Biosciences Investigational Site
Albany, New York, United States
RECRUITINGMBX Biosciences Investigational Site
Greenville, North Carolina, United States
RECRUITINGMBX Biosciences Investigational Site
Summerville, South Carolina, United States
RECRUITINGMBX Biosciences Investigational Site
Dallas, Texas, United States
RECRUITINGMBX Biosciences Investigational Site
Round Rock, Texas, United States
RECRUITINGMBX Biosciences Investigational Site
Shavano Park, Texas, United States
RECRUITING...and 2 more locations