What is canvuparatide studying for hypoparathyroidism?

Canvuparatide is being studied to see how well it works and how safe it is as a weekly treatment for adults with hypoparathyroidism. The research aims to find out if canvuparatide can improve patient outcomes compared to a placebo. The study is sponsored by MBX Biosciences and focuses on this specific condition.

Who may be eligible for this hypoparathyroidism clinical trial?

Adults aged 18 or older with a diagnosis of hypoparathyroidism for at least one year may be eligible. Participants must have stable doses of certain calcium and vitamin D medications and no recent use of related hormone treatments. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this hypoparathyroidism clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07699471

Phase 3 Trial of Weekly Canvuparatide Injection Compared to Placebo in Adults with Hypoparathyroidism

Led by MBX Biosciences · Updated on 2026-07-13

160

Participants Needed

Research Sites

82 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of canvuparatide as a once-weekly treatment for adults with hypoparathyroidism, a condition where the body produces insufficient parathyroid hormone HypoPT. This phase 3 trial compares canvuparatide to a placebo to better understand its effects in this patient population. Participants receive canvuparatide or placebo as a single-use drug-device combination product. Each injection delivers 1 mL of the drug or placebo via a manual subcutaneous injection once weekly. The study includes a randomized, parallel design where participants are assigned to either the canvuparatide or placebo group. Throughout the study, participants are monitored for 26 weeks to measure how many respond to treatment based on key criteria. Researchers will evaluate safety and efficacy during this period. The trial involves regular assessments including blood tests to monitor serum calcium and hormone levels. Participation lasts until study completion in August 2029, with primary outcomes assessed at 26 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years of age or older
Documented diagnosis of post-surgical, chronic, genetic, idiopathic, or autoimmune hypoparathyroidism for at least 12 months
Intact parathyroid hormone (PTH) levels below the median normal range
Stable doses 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
Two consecutive albumin-adjusted serum calcium measurements between 7.8 to 9.4 mg/dL at least one week apart

You will not qualify if you...

History of pseudohypoparathyroidism
Clinically significant abnormal blood tests including hematology, chemistry, or coagulation
Diseases affecting calcium metabolism or PTH levels other than hypoparathyroidism, such as active endogenous hyperthyroidism
Use of therapies affecting calcium metabolism within 4 weeks before randomization
Use of PTH or PTH-related protein drugs within 5 weeks prior to screening

Research Team

Salomon Azoulay, MD

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