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

RecruitingPhase 3Ages 18 Years - anyAllMBX Biosciences
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Canvuparatide
  • Placebo
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Where

21 sites
MBX Biosciences Investigational Site
Englewood, United States
MBX Biosciences Investigational Site
Homestead, United States
MBX Biosciences Investigational Site
Lawrenceville, United States
MBX Biosciences Investigational Site
Metairie, United States
MBX Biosciences Investigational Site
Jackson, United States
MBX Biosciences Investigational Site
Omaha, United States
MBX Biosciences Investigational Site
Las Vegas, United States
MBX Biosciences Investigational Site
Reno, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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