2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening.
3. Intact PTH level below the median value of the normal range
4. 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.
5. Two (2) consecutive measurements of albumin-adjusted serum calcium at least 1 week apart within the range of 7.8 to 9.4 mg/dL (1.95 to 2.35 mmol/L).
You may not be if
1. Has a known history of pseudohypoparathyroidism
2. Clinically significant abnormal hematology, clinical chemistry, or coagulation.
3. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism;
4. Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization
5. PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 5 weeks prior to screening.
Clareo Health | A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
