HypoparathyroidismPhase 2NCT06465108
Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism
A Phase 2 study testing MBX 2109 in people with Hypoparathyroidism, run by MBX Biosciences at 33 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- MBX 2109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 8 Aug 2024to 4 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is an adult ≥18 years of age at the time of the Screening visit.
- If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand
- Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the Screening visit:
- Postsurgical chronic hypoparathyroidism
- Idiopathic hypoparathyroidism
- Autoimmune hypoparathyroidism (e.g., isolated autoimmune hypoparathyroidism; stable, well-managed patients with autoimmune polyglandular syndrome type 1/autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy without current or past malabsorption at the discretion of the principal investigator [PI])
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- On a dose for at least 4 weeks prior to the Screening visit of the following:
- Calcitriol ≥0.5 µg per day or alfacalcidol ≥1 ug per day (active vitamin D)
- Elemental calcium (citrate or carbonate) supplement ≥800 mg per day
- If the patient had a history of hypercalcemia on the above active vitamin D and/or calcium doses, the patient may be eligible to participate in the study on lower doses of calcitriol, alfacalcidol and/or elemental calcium with approval of the medical monitor
- At the Screening visit or at completion of the Optimization Period, the following serum analytes must be within the following ranges:
- AdjCa: 8.2 to 10.6 mg/dL (2.05 to 2.65 mmol/L), inclusive, targeting the lower half of the reference range
- 25 (OH)D: 30 to 64 ng/mL (75 to 160 nmol/L), inclusive
- Magnesium: within the normal range of 1.8 to 2.6 mg/dL (0.65 to 1.05 mmol/L; 1.3 mEq/L to 2.1 mEq/L), inclusive; if the patient had a history of not being successful in maintaining serum magnesium within the normal reference range, a level slightly below the normal range (≥1.3 mg/dL [≥0.53 mmol/L]) may be acceptable with approval by the medical monitor 1.3 mEq/L to 2.1 mEq/L), inclusive
- Has an estimated glomerular filtration rate >60 mL/min/1.73 m2, as estimated using the Chronic Kidney Disease Epidemiology Collaboration equation, at the Screening visit.
- Has thyroid-stimulating hormone (TSH) within normal laboratory limits prior to randomization. If patient is on thyroid medication, the dose should be stable for at least 4 weeks. If TSH is not within normal limits at screening, the dose of thyroid medication may be adjusted and TSH repeated in 4 weeks. If receiving suppressive therapy for a history of (differentiated) thyroid cancer, TSH level must be ≥0.2 mIU/L.
- Can comprehend and is willing to sign an informed consent form (ICF) and to abide by the study restrictions, study visits, and procedures.
Who cannot join
- Has a known history of pseudohypoparathyroidism (impaired responsiveness to PTH, which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia).
- Has any disease (other than hypoparathyroidism) that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels (e.g., disorders of the calcium sensing receptor [e.g., autosomal dominant hypocalcemia type 1] are exclusionary).
- Use any of the following therapies:
- Loop diuretics, thiazide diuretics, phosphate binders (other than calcium carbonate or citrate), digoxin, lithium, methotrexate, raloxifene hydrocholoride, or acute systemic corticosteroids within 4 weeks prior to the Screening Visit;
- Chronic systemic corticosteroid use is allowed if the dose has been stable for 4 weeks prior to Screening visit
- PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 4 weeks of the Screening visit;
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- Oral or intravenous bisphosphonates, denosumab, or romosozumab-aqqg within 18 months of the Screening visit; or
- Other drugs known to influence calcium and bone metabolism such as calcitonin, fluoride tablets (>0.5 mg per day), strontium or cinacalcet hydrochloride within 3 months of the Screening visit.
- Had a non-hypocalcemic seizure within 6 months of the Screening visit. Note: a history of seizures that occur in the setting of hypocalcemia is not exclusionary
- Is at an increased risk for osteosarcoma (e.g., Paget's disease, prior history of substantial external beam or implant radiation therapy involving the skeleton, unexplained elevations of alkaline phosphatase)
- Is affected by active or uncontrolled disease processes that may adversely affect gastrointestinal absorption at the discretion of the PI.
- Has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than differentiated thyroid cancer, basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 2 years from the Screening visit.
- Has any clinically significant cardiovascular disease within 6 months prior to the Screening visit such as symptomatic heart failure, an acute coronary syndrome, uncontrolled arrhythmia, or cerebrovascular accident.
- Has a clinically significant abnormal 12-lead ECG in the opinion of the investigator at the Screening visit suggestive of underlying cardiac disease.
- Has a seated systolic blood pressure <100 mmHg or >165 mmHg and/or diastolic blood pressure >100 mmHg at the Screening visit. If outside this range, measurement can be repeated on another day for eligibility purposes within the Screening Period. If on medications for hypertension, the doses should be stable for 4 weeks prior to the Screening visit.
- Has a history of symptomatic nephrolithiasis within 3 months of the Screening visit.
- Has an episode of acute gout within 2 months of the Screening visit.
- Has any major surgery performed within the 6 months prior to the Screening visit or plans to have surgical procedures that might interfere with the patient's ability to complete the study.
- Is pregnant, lactating or a woman of childbearing potential (WOCBP) who plans to conceive during the study.
- WOCBP must use at least 2 highly effective methods of contraception throughout the study and for 6 weeks following administration of the last dose of study drug.
- A heterosexually active male patient and his female partner(s) of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study drug. A male patient must agree to refrain from sperm donation from the date of screening until 90 days after his last dose of study drug.
- Has any disease or condition that, in the opinion of the investigator, may make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Has a known allergy or sensitivity to PTH or any of the excipients used in MBX 2109.
- Has a diagnosis of drug or alcohol dependence within 12 months prior to the Screening visit.
- Has participated in any other interventional trial in which the patient received an investigational drug within 2 months or within 5 half-lives of the investigational drug (whichever is the longest) prior to the Screening visit.
- Has any other reason that, in the opinion of the investigator, would prevent the patient from completing participation or following the study schedule.
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United States27 sites
MBX Biosciences Investigational Site
Albany, New York, 12203
MBX Biosciences Investigational Site
Chicago, Illinois, 60611
MBX Biosciences Investigational Site
Chicago, Illinois, 60637
MBX Biosciences Investigational Site
Cleveland, Ohio, 44195
MBX Biosciences Investigational Site
Columbus, Ohio, 43201
MBX Biosciences Investigational Site
Dallas, Texas, 75208
MBX Biosciences Investigational Site
El Paso, Texas, 79935
MBX Biosciences Investigational Site
Fort Worth, Texas, 76132
MBX Biosciences Investigational Site
Great Neck, New York, 10021
MBX Biosciences Investigational Site
Greenville, North Carolina, 27834
MBX Biosciences Investigational Site
Jackson, Mississippi, 39202
MBX Biosciences Investigational Site
Jacksonville, Florida, 32204
MBX Biosciences Investigational Site
Jacksonville, Florida, 32216
MBX Biosciences Investigational Site
Las Vegas, Nevada, 89148
MBX Biosciences Investigational Site
Macon, Georgia, 31210
MBX Biosciences Investigational Site
Madison, Wisconsin, 53705
MBX Biosciences Investigational Site
Miami, Florida, 33033
MBX Biosciences Investigational Site
New York, New York, 10032
MBX Biosciences Investigational Site
Omaha, Nebraska, 68198
MBX Biosciences Investigational Site
Philadelphia, Pennsylvania, 19107
MBX Biosciences Investigational Site
Reno, Nevada, 89511
MBX Biosciences Investigational Site
Round Rock, Texas, 78681
MBX Biosciences Investigational Site
Sacramento, California, 95817
MBX Biosciences Investigational Site
San Antonio, Texas, 78231
MBX Biosciences Investigational Site
St Louis, Missouri, 63110
MBX Biosciences Investigational Site
The Bronx, New York, 10467
MBX Biosciences Investigational Site
Weslaco, Texas, 78596
Argentina5 sites
MBX Biosciences Investigational Site
CABA, Buenos Aires, C1012AAR
MBX Biosciences Investigational Site
CABA, Buenos Aires, C1425AGC
MBX Biosciences Investigational Site
Córdoba, X5000AAW
MBX Biosciences Investigational Site
Río Cuarto, Córdoba Province, X5800AEV
MBX Biosciences Investigational Site
San Miguel de Tucumán, T4000IEH
Turkey (Türkiye)1 site
MBX Biosciences Investigational Site
Samsun, 55270
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)
The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.
Read the detailed description
This study is to investigate the safety, pharmacokinetics, and efficacy of MBX 2109 administered once weekly to patients with hypoparathyroidism. Given MBX 2109 is intended as a parathyroid hormone (PTH) replacement hormone to demonstrate that MBX 2109 can maintain serum calcium within a normal range without the need for active vitamin D and therapeutic calcium supplements.
- Conditions
- Hypoparathyroidism
- Being tested
- MBX 2109, Placebo
- Keywords
- Hypoparathyroid, Hypopara, Thyroid, MBX 2109
- Medical subject headings
- Hypoparathyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBX 2109Drug
Also called Canvuparatide
Supplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL
PlaceboOther
Supplied in 1.4 mL water for injection
| Study group | Role | What they receive |
|---|---|---|
| Starting dose of 400 µg once-weekly by subcutaneous injection | Experimental | Not described Receives: Drug: MBX 2109 |
| Starting dose of 600 µg once-weekly by subcutaneous injection | Experimental | Not described Receives: Drug: MBX 2109 |
| Starting dose of 800 µg once-weekly by subcutaneous injection | Experimental | Not described Receives: Drug: MBX 2109 |
| Placebo - once-weekly by subcutaneous injection | Placebo comparator | Not described 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 MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15
Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12/Visit 15
- Independence from active vitamin D supplements
- Oral elemental calcium doses of ≤600 mg/day
- Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start8 Aug 2024
- Primary completion23 May 2025
- Study completion4 Jun 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- MBX Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465108
- Sponsor's protocol ID
- MBX-2H1002
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)
- ClinicalTrials.gov ID
- NCT06465108
- Acronym / sponsor ID
- MBX-2H1002
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroid, Hypopara, Thyroid, MBX 2109
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 18 Jun 2024 (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 safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.
Detailed description
This study is to investigate the safety, pharmacokinetics, and efficacy of MBX 2109 administered once weekly to patients with hypoparathyroidism. Given MBX 2109 is intended as a parathyroid hormone (PTH) replacement hormone to demonstrate that MBX 2109 can maintain serum calcium within a normal range without the need for active vitamin D and therapeutic calcium supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Starting dose of 400 µg once-weekly by subcutaneous injection | Experimental | Drug: MBX 2109 |
| Starting dose of 600 µg once-weekly by subcutaneous injection | Experimental | Drug: MBX 2109 |
| Starting dose of 800 µg once-weekly by subcutaneous injection | Experimental | Drug: MBX 2109 |
| Placebo - once-weekly by subcutaneous injection | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Is an adult ≥18 years of age at the time of the Screening visit.
- Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the Screening visit:
- On a dose for at least 4 weeks prior to the Screening visit of the following:
- At the Screening visit or at completion of the Optimization Period, the following serum analytes must be within the following ranges:
- Has an estimated glomerular filtration rate >60 mL/min/1.73 m2, as estimated using the Chronic Kidney Disease Epidemiology Collaboration equation, at the Screening visit.
Key exclusion criteria (26 listed)
- Has a known history of pseudohypoparathyroidism (impaired responsiveness to PTH, which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia).
- Has any disease (other than hypoparathyroidism) that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels (e.g., disorders of the calcium sensing receptor [e.g., autosomal dominant hypocalcemia type 1] are exclusionary).
- Use any of the following therapies:
- Had a non-hypocalcemic seizure within 6 months of the Screening visit. Note: a history of seizures that occur in the setting of hypocalcemia is not exclusionary
- Is at an increased risk for osteosarcoma (e.g., Paget's disease, prior history of substantial external beam or implant radiation therapy involving the skeleton, unexplained elevations of alkaline phosphatase)
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 |
|---|---|---|
| MBX 2109Also: CanvuparatideSupplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL | Drug | Starting dose of 400 µg once-weekly by subcutaneous injection, Starting dose of 600 µg once-weekly by subcutaneous injection, Starting dose of 800 µg once-weekly by subcutaneous injection |
| PlaceboSupplied in 1.4 mL water for injection | Other | Placebo - once-weekly by subcutaneous injection |
Primary outcome
To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15
Time frame: Week 12
Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12/Visit 15 * Independence from active vitamin D supplements * Oral elemental calcium doses of ≤600 mg/day * Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBX 2109 in people with Hypoparathyroidism, run by MBX Biosciences at 33 sites in 3 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 17 inclusion and 26 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: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Argentina, Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15 (time frame: Week 12). 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 20 Mar 2026.