A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
ConditionHypoparathyroidism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMBX Biosciences
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is an adult ≥18 years of age.
Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening.
Intact PTH level below the median value of the normal range
Minimum requirement for a dose of calcitriol ≥0.5 μg/day, or alfacalcidol ≥1.0 μg/day and (elemental) calcium ≥1000 mg/day for at least 12 weeks prior to screening. In addition, the doses of calcitriol, or alfacalcidol, and calcium should be stable for at least 3 weeks prior to screening.
Disqualifiers
Has a known history of pseudohypoparathyroidism
Clinically significant abnormal hematology, clinical chemistry, or coagulation.
Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism;
Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization
Trial design
Design model
Parallel
Treatments tested in this trial
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 intervention• 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: CanvuparatideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 WeeksSponsors and contacts
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Source ClinicalTrials.gov