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
Qualifiers
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
Treatments tested in this trial
- Canvuparatide
- Placebo
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov