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New shot could help thyroid patients who Don't respond to usual pills

NCT ID NCT07596849

Disease control Sponsor: argenx 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests an investigational drug called efgartigimod for adults with Graves' disease whose thyroid levels are still high despite taking standard antithyroid medications. About 230 participants will receive either the drug or a placebo as a shot under the skin. The goal is to see if the drug can help bring thyroid hormone levels back to normal and allow patients to reduce or stop their current pills.

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 230 people

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

Started

Jun 2026

Expected to finish

May 2030

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.

Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. * Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \>=ULN (upper limit of normal) at screening * Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \<0.1 mIU/L at screening * Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening Exclusion Criteria: * History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter) * History of RAI (radioactive iodine) therapy or received a total thyroidectomy * T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \<6 weeks before screening * Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications. * Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study

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Conditions

The condition(s) this trial relates to.

Graves disease

As listed by the trial registrant

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

Graves disease

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aso Iizuka Hospital

    RECRUITING

    Iizuka, 820-8505, Japan

  • Centrum Medyczne INTERCOR Sp. z o.o.

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, 85-605, Poland

  • ETC Zamosc

    ACTIVE_NOT_RECRUITING

    Zamość, 22400, Poland

  • Endocrinologie Oasis

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H4J1E3, Canada

  • First Medical Clinic Ltd

    RECRUITING

    Tbilisi, 0102, Georgia

  • High Technology Hospital Medcenter LLC

    RECRUITING

    Batumi, 6000, Georgia

  • Hospital of Lithuanian University of Health Sciences Kaunas

    ACTIVE_NOT_RECRUITING

    Kaunas, Kauno, 50161, Lithuania

  • Hospital of University of Occupational and Environmental Health

    RECRUITING

    Kitakyushu, 807-8556, Japan

  • Ito Hospital

    RECRUITING

    Shibuya City, 150-8308, Japan

  • LTD MediClub Georgia

    RECRUITING

    Tbilisi, 0160, Georgia

  • Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD

    ACTIVE_NOT_RECRUITING

    Sliven, 8800, Bulgaria

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, 852-8501, Japan

  • National Hospital Organization Kyoto Medical Center

    RECRUITING

    Kyoto, 612-0861, Japan

  • Nippon Medical School Musashikosugi Hospital

    RECRUITING

    Kawasaki, 211-8533, Japan

  • SHOWA Medical University Northern Yokohama Hospital

    RECRUITING

    Yokohama, 224-8503, Japan

  • TLC Diabetes and Endocrinology Clinic

    RECRUITING

    Surrey, V3T 2V6, Canada

  • Tottori University Hospital

    RECRUITING

    Yonago, 683-8504, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.