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New Once-Weekly shot shows promise for Long-Term hypoparathyroidism control

NCT ID NCT06531941

Disease control Sponsor: MBX Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of an experimental drug called MBX 2109 for people with hypoparathyroidism, a condition where the body doesn't produce enough parathyroid hormone. About 60 adults who finished a 12-week phase 2 study will receive weekly injections of MBX 2109 for an extended period. The main goal is to track any side effects and see if the drug remains safe over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MBX 2109 (a once-weekly injection)
What this could lead to
If successful, this could point toward a long-term treatment option for hypoparathyroidism that is safe and well-tolerated.
What could go wrong
This is a small, early-phase extension study focused on safety, not effectiveness. It may not show clear benefit, and side effects could emerge with longer use.
Why investors are watching

MBX Biosciences is testing MBX 2109 in an extension study for people with hypoparathyroidism who finished a 12-week Phase 2 trial. The study follows up to 60 participants to see whether the drug stays safe and tolerable over a longer period. For a micro-cap company, this longer-term safety data matters because regulators and partners want to see whether the treatment holds up beyond the first few months.

If it works: If the drug remains safe and tolerable over the extension period, MBX Biosciences may have stronger evidence to support later-stage testing and could attract partners or financing.

If it fails: If safety problems or tolerability issues appear during longer treatment, the company may need to change the drug, slow development, or stop the program. Most clinical trials fail, and small companies have little room for setbacks.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Oct 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Must have completed the Week 12 Visit in MBX-2H1002 Study. 2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study. 3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the Screening visit: 1. Postsurgical chronic hypoparathyroidism 2. Idiopathic hypoparathyroidism 3. Autoimmune hypoparathyroidism 4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures. 5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

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Conditions

The condition(s) this trial relates to.

hypoparathyroidism thyroid gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoparathyroidism

Contacts and locations

Locations

  • MBX Biosciences Investigational Site

    Miami, Florida, 33033, United States

  • MBX Biosciences Investigational Site

    Macon, Georgia, 31210, United States

  • MBX Biosciences Investigational Site

    Jackson, Mississippi, 39202, United States

  • MBX Biosciences Investigational Site

    St Louis, Missouri, 63110, United States

  • MBX Biosciences Investigational Site

    Las Vegas, Nevada, 89148, United States

  • MBX Biosciences Investigational Site

    Reno, Nevada, 89511, United States

  • MBX Biosciences Investigational Site

    Albany, New York, 12203, United States

  • MBX Biosciences Investigational Site

    New York, New York, 10032, United States

  • MBX Biosciences Investigational Site

    The Bronx, New York, 10467, United States

  • MBX Biosciences Investigational Site

    Columbus, Ohio, 43201, United States

  • MBX Biosciences Investigational Site

    Dallas, Texas, 75208, United States

  • MBX Biosciences Investigational Site

    El Paso, Texas, 79935, United States

  • MBX Biosciences Investigational Site

    Fort Worth, Texas, 76132, United States

  • MBX Biosciences Investigational Site

    Round Rock, Texas, 78681, United States

  • MBX Biosciences Investigational Site

    San Antonio, Texas, 78231, United States

  • MBX Biosciences Investigational Site

    Weslaco, Texas, 78596, United States

  • MBX Biosciences Investigational Site

    Madison, Wisconsin, 53705, United States

  • MBX Biosciences Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina

  • MBX Biosciences Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC, Argentina

  • MBX Biosciences Investigational Site

    Córdoba, Río Cuarto, X5800AEV, Argentina

  • MBX Biosciences Investigational Site

    Córdoba, X5000AAW, Argentina

  • MBX Biosciences Investigational Site

    San Miguel de Tucumán, T4000IEH, Argentina

  • MBX Biosciences Investigational Site

    Samsun, 55270, Turkey (Türkiye)

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