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New shot could tame thyroid eye disease

NCT ID NCT06812325

Disease control Sponsor: Viridian Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests an investigational drug called VRDN-003, given as an injection under the skin, for people with thyroid eye disease. The study involves 320 participants and aims to check the drug's safety and tolerability. Researchers will also measure if it reduces eye bulging. The trial is active but not currently recruiting.

What this could mean

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

Active substance
VRDN-003 (a monoclonal antibody injection)
What this could lead to
If successful, this could lead to a new treatment option for thyroid eye disease that may reduce eye bulging and improve symptoms.
What could go wrong
This is still an early-stage trial focused on safety, so it is not yet proven to work. The drug may cause side effects or fail to show benefit.

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

320 people

The number who actually took part.

Started

Feb 2025

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

18 to 75 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: * Have a clinical diagnosis of TED with or without proptosis and with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003 * Not require immediate ophthalmological or orbital surgery in the study eye for any reason. * Must agree to use highly effective contraception as specified in the protocol * Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteria: * Must not have received prior treatment with another anti-IGF-1R therapy * Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose. * Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose * Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit * Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor * Must not have a history of inflammatory bowel disease * Female TED participants must not be pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

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

Thyroid eye disease, ted

Contacts and locations

Locations

  • Abeillon du Payrat

    Bron, 69500, France

  • Addenbrookes Hospital

    Cambridge, United Kingdom

  • Advanced Quality Medical Research

    Orland Park, Illinois, 60462, United States

  • Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı

    Antalya, 07059, Turkey (Türkiye)

  • Alfa Medical Research

    Davie, Florida, 33024, United States

  • C A Clinical Trial Corp.

    Cape Coral, Florida, 33990, United States

  • California Eye Specialists Medical Group INC

    Pasadena, California, 91107, United States

  • Catalina Eye Care

    Tuscon, Arizona, 85712, United States

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338, Poland

  • Centrum Medyczne Pulawska Sp. z o.o.

    Piaseczno, 05-500, Poland

  • Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum

    Berlin, Germany

  • Clinica Universidad de Navarre

    Navarrés, Spain

  • Continental Clinical Research

    Miami, Florida, 33144, United States

  • D H Doral Research Center

    Doral, Florida, 33132, United States

  • DFW Clinical Trials

    Carrollton, Texas, 75010, United States

  • ETG Lublin

    Lublin, 20-412, Poland

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216, United States

  • Edward Jenner Research Group LLC

    Plantation, Florida, 33317, United States

  • Elevate Clinical Research

    Seabrook, Texas, 77586, United States

  • Eye Centers of Florida

    Fort Myers, Florida, 33901, United States

  • Eyeplastx

    San Antonio, Texas, 78258, United States

  • FOMAT Medical Research

    Pismo Beach, California, 93030, United States

  • Fraser Eye Care Center

    Fraser, Michigan, 48026, United States

  • Gazi University Medical Faculty Hospital

    Ankara, Turkey (Türkiye)

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Hacettepe Univeristy Medical Fculty Hospital

    Ankara, Turkey (Türkiye)

  • Herco Medical and Research Center

    Coral Gables, Florida, 33134, United States

  • Hospital La Arruzafa

    Córdoba, 14012, Spain

  • Hospital Provincial de Conxo

    A Coruña, 15706, Spain

  • Hospital Universitario Miguel Servet Consultas de Oftalmologia

    Zaragoza, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hôpital La Pitiélsalpêtrière

    Paris, France

  • Imperial College Healthcare NHS Trust

    London, NW1 5QH, United Kingdom

  • Institut Català de Retina

    Barcelona, 08017, Spain

  • Jackson Clinic

    Jackson, Tennessee, 38305, United States

  • Johannes Gutenberg University Medical Center Department of Medicine 1

    Mainz, Germany

  • Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği

    Istanbul, Turkey (Türkiye)

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Moorefields Eye Hospital NHS Foundation Trust

    London, United Kingdom

  • Neuro Eye Clinical Trials

    Houston, Texas, 77074, United States

  • Ophthalmic Consultants of Boston

    East Weymouth, Massachusetts, 02189, United States

  • Optimum Profesorskie Centrum Okulistyki Sp. z o. o.

    Gdansk, 80-180, Poland

  • Orbital Plastics

    Newport Beach, California, 92660, United States

  • Pacific Neuroscience Institute

    Santa Monica, California, 90404, United States

  • Pacific Neuroscience Institute at Saint John's Physician Partners

    Torrance, California, 90503, United States

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099, United States

  • Polimedica PTG

    Warsaw, 02-777, Poland

  • Retreat Medical Research

    Miami, Florida, 33135, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240, United States

  • Santa Familia PTG Lodz

    Lodz, 90-302, Poland

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers

    Angers, France

  • Sina Medical Center

    Homestead, Florida, 33034, United States

  • Southern Clinical Research LLC

    Miami, Florida, 33125, United States

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, United Kingdom

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • Universitaetsmedizin Goettingen

    Göttingen, 37075, Germany

  • Universitatsklinikum Essen

    Essen, Germany

  • University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit

    Bristol, United Kingdom

  • University of Missouri Kansas City

    Kansas City, Missouri, 64108, United States

  • Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych

    Bialystok, 15-276, Poland

  • Warszawski Szpital Okulistyczny

    Warsaw, 01-258, Poland

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