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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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).

What is being tested

Sponsor: MBX Biosciences · Participants: 160 · Started: Aug 26, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07699471

Locations in the U.S.

FloridaMBX Biosciences Investigational Site, Homestead
LouisianaMBX Biosciences Investigational Site, Metairie
NevadaMBX Biosciences Investigational Site, Las Vegas
MBX Biosciences Investigational Site, Reno
New YorkMBX Biosciences Investigational Site, Albany
North CarolinaMBX Biosciences Investigational Site, Greenville
South CarolinaMBX Biosciences Investigational Site, Summerville
TexasMBX Biosciences Investigational Site, Dallas
MBX Biosciences Investigational Site, Round Rock
MBX Biosciences Investigational Site, Shavano Park
MBX Biosciences Investigational Site, Weslaco
WashingtonMBX Biosciences Investigational Site, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.