Recruiting
Phase 3

Canvuparatide

Sponsor:

MBX Biosciences

Code:

NCT07699471

Conditions

Hypoparathyroidism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Canvuparatide

Placebo

Study Details

Brief summary:

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).

Conditions

Hypoparathyroidism

Study ID

NCT07699471

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Canvuparatide

Canvuparatide is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of canvuparatide via a manual SC injection. Dosing is once weekly.

placebo comparator: Placebo

Placebo is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of placebo via a manual SC injection. Dosing is once weekly.

Interventions

Canvuparatide

• 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.

Placebo

• 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 outcome measure

  • To evaluate the effect of pooled weekly doses of canvuparatide on the proportion of responder patients at week 26. [ Time Frame: 26 Weeks ]

Central Contacts and Locations

Central contacts

Salomon Azoulay, MD

13176590200

Locations

MBX Biosciences Investigational Site

Recruiting

Homestead, Florida, United States, 33030

MBX Biosciences Investigational Site

Recruiting

Metairie, Louisiana, United States, 70002

MBX Biosciences Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89148

MBX Biosciences Investigational Site

Recruiting

Reno, Nevada, United States, 89511

MBX Biosciences Investigational Site

Recruiting

Albany, New York, United States, 12208

MBX Biosciences Investigational Site

Recruiting

Greenville, North Carolina, United States, 27834

MBX Biosciences Investigational Site

Recruiting

Summerville, South Carolina, United States, 29485

MBX Biosciences Investigational Site

Recruiting

Dallas, Texas, United States, 75208

MBX Biosciences Investigational Site

Recruiting

Round Rock, Texas, United States, 78681

MBX Biosciences Investigational Site

Recruiting

Shavano Park, Texas, United States, 78231

MBX Biosciences Investigational Site

Recruiting

Weslaco, Texas, United States, 78596

MBX Biosciences Investigational Site

Recruiting

Spokane, Washington, United States, 99216

More Information

Sponsor

MBX Biosciences

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MBX Biosciences on 2026-08-31.