HypoparathyroidismPhase 2NCT06531941
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
A Phase 2 study testing 400 µg of MBX 2109 once-weekly by subcutaneous injection and 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection in people with Hypoparathyroidism, run by MBX Biosciences at 23 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- 400 µg of MBX 2109 once-weekly by subcutaneous injection and 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 31 Oct 2024to May 2028
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have completed the Week 12 Visit in MBX-2H1002 Study.
- Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
- 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
Show all 9Show fewer
- Autoimmune hypoparathyroidism
- Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
- In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
Who cannot join
None listed.
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States17 sites
MBX Biosciences Investigational Site
Albany, New York, 12203
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
Jackson, Mississippi, 39202
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
Reno, Nevada, 89511
MBX Biosciences Investigational Site
Round Rock, Texas, 78681
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
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR
MBX Biosciences Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC
MBX Biosciences Investigational Site
Córdoba, Córdoba Province, X5000AAW
MBX Biosciences Investigational Site
Córdoba, Río Cuarto, X5800AEV
MBX Biosciences Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000IEH
Turkey (Türkiye)1 site
MBX Biosciences Investigational Site
Samsun, 55270
About this study
Official title: An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)
The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.
Read the detailed description
This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.
- Conditions
- Hypoparathyroidism
- Being tested
- 400 µg of MBX 2109 once-weekly by subcutaneous injection, 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection
- 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.
400 µg of MBX 2109 once-weekly by subcutaneous injectionDrug
Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL.
Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly
200-1600 µg of MBX 2109 once-weekly by subcutaneous injectionDrug
Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL.
Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002.
The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections.
| Study group | Role | What they receive |
|---|---|---|
| 400 µg once-weekly by subcutaneous injection | Experimental | Not described Receives: Drug: 400 µg of MBX 2109 once-weekly by subcutaneous injection |
| 200-1600 µg once-weekly by subcutaneous injection | Experimental | Not described Receives: Drug: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start31 Oct 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06531941
- Sponsor's protocol ID
- MBX-2H1004
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)
- ClinicalTrials.gov ID
- NCT06531941
- Acronym / sponsor ID
- MBX-2H1004
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroid, Hypopara, Thyroid, MBX 2109
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Aug 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 evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.
Detailed description
This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 µg once-weekly by subcutaneous injection | Experimental | Drug: 400 µg of MBX 2109 once-weekly by subcutaneous injection |
| 200-1600 µg once-weekly by subcutaneous injection | Experimental | Drug: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must have completed the Week 12 Visit in MBX-2H1002 Study.
- Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
- Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
- Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
- In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 400 µg of MBX 2109 once-weekly by subcutaneous injectionSupplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly | Drug | 400 µg once-weekly by subcutaneous injection |
| 200-1600 µg of MBX 2109 once-weekly by subcutaneous injectionSupplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002. The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections. | Drug | 200-1600 µg once-weekly by subcutaneous injection |
Primary outcome
To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
Time frame: 104 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
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 7 Oct 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.
23 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 400 µg of MBX 2109 once-weekly by subcutaneous injection and 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection in people with Hypoparathyroidism, run by MBX Biosciences at 23 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 9 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 7 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 23 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. 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?
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?
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 long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism. (time frame: 104 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 7 Oct 2026.