NCT07699471

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
37mo left

Started Aug 2026

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

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

    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

    26 Weeks

Study Arms (2)

Canvuparatide

ACTIVE COMPARATOR

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.

Drug: Canvuparatide

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

CanvuparatideDRUG

• 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.

Also known as: MBX 2109
Canvuparatide
PlaceboOTHER

• 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MBX Biosciences Investigational Site

Homestead, Florida, 33030, United States

RECRUITING

MBX Biosciences Investigational Site

Shavano Park, Texas, 78231, United States

RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Central Study Contacts

Salomon Azoulay, MD

CONTACT

844-877-4473

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

US(2)