HypoparathyroidismPhase 3NCT07699471
A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
A Phase 3 study testing Canvuparatide in people with Hypoparathyroidism, run by MBX Biosciences at 21 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Canvuparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 26 Aug 2026to Aug 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Salomon Azoulay, MD contact
21 sites in 2 countries
United States20 sites, 20 recruiting
- Recruiting
MBX Biosciences Investigational Site
Albany, New York, 12208
- Recruiting
MBX Biosciences Investigational Site
Columbus, Ohio, 43210
- Recruiting
MBX Biosciences Investigational Site
Dallas, Texas, 75208
- Recruiting
MBX Biosciences Investigational Site
Edinburg, Texas, 78539
- Recruiting
MBX Biosciences Investigational Site
Englewood, Colorado, 80113
- Recruiting
MBX Biosciences Investigational Site
Greenville, North Carolina, 27834
- Recruiting
MBX Biosciences Investigational Site
Homestead, Florida, 33030
- Recruiting
MBX Biosciences Investigational Site
Jackson, Mississippi, 39202
- Recruiting
MBX Biosciences Investigational Site
Las Vegas, Nevada, 89148
- Recruiting
MBX Biosciences Investigational Site
Lawrenceville, Georgia, 30046
- Recruiting
MBX Biosciences Investigational Site
Metairie, Louisiana, 70002
- Recruiting
MBX Biosciences Investigational Site
Omaha, Nebraska, 68198
- Recruiting
MBX Biosciences Investigational Site
Reno, Nevada, 89511
- Recruiting
MBX Biosciences Investigational Site
Round Rock, Texas, 78681
- Recruiting
MBX Biosciences Investigational Site
Shavano Park, Texas, 78231
- Recruiting
MBX Biosciences Investigational Site
Spokane, Washington, 99216
- Recruiting
MBX Biosciences Investigational Site
Summerville, South Carolina, 29485
- Recruiting
MBX Biosciences Investigational Site
Syracuse, New York, 13210
- Recruiting
MBX Biosciences Investigational Site
The Bronx, New York, 10467
- Recruiting
MBX Biosciences Investigational Site
Weslaco, Texas, 78596
Canada1 site, 1 recruiting
- Recruiting
MBX Biosciences Investigational Site
Oakville, Ontario
About this study
Official 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
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
- Being tested
- Canvuparatide, Placebo
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanvuparatideDrug
Also called MBX 2109
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start26 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MBX Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699471
- Sponsor's protocol ID
- MBX-2H1005
- Other IDs
- 2026-525326-37-00
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No