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Recruiting NCT07699471

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

Conditions: Hypoparathyroidism

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 160
Sponsor: MBX Biosciences

Location: MBX Biosciences Investigational Site Homestead Florida

Summary

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

Key Inclusion Criteria: 1. Is an adult ≥18 years of age. 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). Key Exclusion Criteria: 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07699471). StuddyBuddy aggregates publicly available trial information.