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NCT07699471From ClinicalTrials.govRecruiting

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Followed by an Open-Label Extension to Evaluate the Safety and Efficacy of Canvuparatide (MBX 2109) in Adult Patients With Hypoparathyroidism

  • Hypoparathyroidism

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
MBX Biosciences
Enrolment target
160
Started
26 August 2026
Main results due
January 2028
Study sites
12
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(12)

  • MBX Biosciences Investigational Site

    Homestead, Florida, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Metairie, Louisiana, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Las Vegas, Nevada, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Reno, Nevada, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Albany, New York, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Greenville, North Carolina, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Summerville, South Carolina, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Dallas, Texas, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Round Rock, Texas, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Shavano Park, Texas, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Weslaco, Texas, United States

    Recruiting

  • MBX Biosciences Investigational Site

    Spokane, Washington, United States

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07699471. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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