Can a replacement enzyme keep calcium buildup in check?

NCT ID NCT06462547

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests the long-term safety of a drug called INZ-701 in people with rare genetic conditions that cause abnormal calcium buildup in the body. The study enrolls people who have already received INZ-701 in an earlier trial and want to continue treatment. Researchers will monitor side effects and check whether the body develops antibodies against the drug. The goal is to see if INZ-701 can be a safe, ongoing treatment for these conditions.

What this could mean

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

Active substance
INZ-701, a recombinant fusion protein designed to replace the missing ENPP1 enzyme
What this could lead to
If successful, this could support a long-term treatment option for people with ENPP1 or ABCC6 deficiency, potentially slowing or preventing harmful calcium buildup in blood vessels and tissues.
What could go wrong
This is a small, open-label study focused on safety, not effectiveness. The drug may cause side effects or immune reactions, and long-term benefits are not yet proven.

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

22 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Oct 2026

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

1 year 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.

Individuals eligible to participate must meet all of the following inclusion criteria: 1. Provide written or electronic informed consent after the nature of the study has been explained, and prior to any research-related procedures, per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) 2. Provide assent in accordance with local regulations, if \<18 years of age 3. Male or female, greater than 1 year of age 4. Must have completed the protocol-required safety and PK/PD and/or efficacy period(s) of a previous INZ-701 clinical study in ENPP1 or ABCC6 Deficiency, as confirmed by the Sponsor 5. Female participants of childbearing potential who are sexually active must be using or agree to use 1 highly effective form of contraception (per CTFG 2020) from at least 1 month before the first dose of INZ-701 through 30 days after last dose of INZ-701 (greater than 5 half-lives of INZ-701); participants must agree to not donate ova from the period following the first dose of INZ-701 through 30 days after the last dose of INZ-701 6. Male participants who are sexually active must agree to use condoms from the period following the first dose of INZ-701 through 30 days after the last dose of INZ-701; participants must agree to not donate sperm from the period following the first dose of INZ-701 through 30 days after last dose of INZ-701 7. In the opinion of the Investigator, able to complete all aspects of the study Individuals who meet any of the following exclusion criteria will not be eligible to participate: 1. In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality not associated with ENPP1 Deficiency or ABCC6 Deficiency, that will preclude study participation and/or may confound interpretation of study results 2. Known intolerance to INZ-701 or any of its excipients 3. Concurrent participation in another interventional clinical study and/or has received an investigational drug other than INZ-701 within 5 half-lives or within 4 weeks prior to the first dose of INZ-701 in this study, whichever is longer, or use of an investigational device 4. Pregnant, trying to become pregnant, or breastfeeding 5. Male participants trying to father a child

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinilabs Drug Development Corporation

    Eatontown, New Jersey, 07724, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical Research Network Ltd.

    Milton Keynes, United Kingdom

  • Necker-Enfants Malades Hospital

    Paris, France

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, Germany

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