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Weekly shot could free hypoparathyroidism patients from daily pills

NCT ID NCT07699471

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether a once-weekly injection of canvuparatide (MBX 2109) can help adults with hypoparathyroidism reduce their daily calcium and vitamin D supplements while keeping blood calcium in a healthy range. The study includes 160 participants who will receive either the drug or a placebo for 26 weeks, followed by an open-label extension. The goal is to see if more people on the drug can become independent of active vitamin D and high-dose calcium supplements compared to those on placebo.

What this could mean

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

Active substance
canvuparatide (MBX 2109)
What this could lead to
If successful, this once-weekly injection could allow many people with hypoparathyroidism to reduce or stop daily calcium and vitamin D supplements while keeping their blood calcium levels normal.
What could go wrong
This is a Phase 3 trial, so earlier results were promising but not definitive. The treatment may not work for everyone, and side effects or the need for dose adjustments are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 years and older

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. Is an adult ≥18 years of age. 2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening. 3. Intact PTH level below the median value of the normal range 4. 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. 5. 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: 1. Has a known history of pseudohypoparathyroidism 2. Clinically significant abnormal hematology, clinical chemistry, or coagulation. 3. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism; 4. Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization 5. PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 5 weeks prior to screening.

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Conditions

The condition(s) this trial relates to.

hypoparathyroidism

As listed by the trial registrant

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

Hypoparathyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MBX Biosciences Investigational Site

    RECRUITING

    Homestead, Florida, 33030, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Metairie, Louisiana, 70002, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89148, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Reno, Nevada, 89511, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Albany, New York, 12208, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Summerville, South Carolina, 29485, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Dallas, Texas, 75208, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Round Rock, Texas, 78681, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Shavano Park, Texas, 78231, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Weslaco, Texas, 78596, United States

  • MBX Biosciences Investigational Site

    RECRUITING

    Spokane, Washington, 99216, United States

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