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 22 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
- 22 sitesin 2 countries
- Study dates
- 26 Aug 2026to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Salomon Azoulay, MD contact
22 sites in 2 countries
United States21 sites, 21 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
Madison, Wisconsin, 53706
- 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
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07699471
- Acronym / sponsor ID
- MBX-2H1005
- Conditions
- Hypoparathyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canvuparatide | Active comparator | Drug: CanvuparatideCanvuparatide 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 | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanvuparatideAlso: 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. | Drug | Canvuparatide |
| 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. | Other | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salomon Azoulay, MD contact
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canvuparatide in people with Hypoparathyroidism, run by MBX Biosciences at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salomon Azoulay, MD (13176590200), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.