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NCT Number: NCT07699471

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

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).

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MBX Biosciences Investigational Site, Homestead, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Is an adult ≥18 years of age.
  • Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening.
  • Intact PTH level below the median value of the normal range
  • 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.
  • 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:

  • Has a known history of pseudohypoparathyroidism
  • Clinically significant abnormal hematology, clinical chemistry, or coagulation.
  • Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism;
  • Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization
  • PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 5 weeks prior to screening.

Treatment and study plan

Canvuparatide

Drug
  • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL.

Other names: MBX 2109

Placebo

Other
  • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL.

Primary outcomes

  1. To evaluate the effect of pooled weekly doses of canvuparatide on the proportion of responder patients at week 26.

    Time frame: 26 Weeks

    Responder status is defined as a study participant who meets the following composite criteria:

    • Independence from active vitamin D
    • Independence from therapeutic doses of calcium (standing elemental calcium dose of ≤ 600 mg/day)
    • 2 consecutive albumin-adjusted serum calcium results in the normal range (8.3-10.6 mg/dL) (2.07-2.64 mmol/L)
    • No increase in study drug

Study contacts

Contact information is provided by the study sponsor or research team.

Salomon Azoulay, MD

CONTACT

844-877-4473

Sponsors and collaborators

Lead sponsor

MBX Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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