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New drug shows promise for bulging eyes in thyroid disease

NCT ID NCT06384547

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This completed Phase 3 trial tested a drug called VRDN-001 in 231 people with thyroid eye disease (TED). The drug works by blocking a receptor involved in inflammation and swelling. The main goal was to check safety and tolerability, with secondary goals including measuring changes in eye bulging. Participants received five infusions of either a low or high dose of the drug.

What this could mean

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

Active substance
VRDN-001 (a monoclonal antibody that blocks the IGF-1 receptor)
What this could lead to
If successful, this could lead to a new treatment option that reduces eye bulging and inflammation in people with thyroid eye disease.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may cause side effects, and it is not a cure—patients may still need ongoing care.

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

231 people

The number who actually took part.

Started

May 2024

Finished

Jan 2026

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.

Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment * Must agree to use highly effective contraception method as specified in the protocol * Female TED participants must have a negative serum pregnancy test at screening * Not require immediate ophthalmological or orbital surgery in the study eye for any reason. Exclusion Criteria: * Must not have received prior treatment with another anti-IGF-1R therapy * Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1 * Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1 * Must not have received any other therapy for TED within 8 weeks prior to Day 1 * Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication * Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results * Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit * Must not have inflammatory bowel disease * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor. * Female TED participants must not be pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves disease Graves Ophthalmopathy

As listed by the trial registrant

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

Thyroid eye disease

Contacts and locations

Locations

  • 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, 53-114, Poland

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris, 75013, France

  • Advancing Research International, LLC

    Los Angeles, California, 90023, United States

  • Advancing Research International, LLC

    Las Vegas, Nevada, 89144, United States

  • Baylor College of Medicine (BCM) - Ophthalmology

    Houston, Texas, 77030, United States

  • CH Nice

    Nice, 06000, France

  • CHU d'Angers

    Angers, 49100, France

  • Centre Hospitalier National D'ophtalmologie

    Des Quinze Vingts Paris, 75012, France

  • Clinica Bonanova de Cirugia Ocular

    Barcelona, 08022, Spain

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Clínica Universidad de Navarra

    Madrid, 28027, Spain

  • Cockerham Eye Consultants, PC

    San Diego, California, 92108, United States

  • Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo

    Santiago de Compostela, A Coruña, 15706, Spain

  • Edward Jenner Research Group Center LLC

    Plantation, Florida, 33317, United States

  • FOMAT Medical Research

    Santa Maria, California, 93454, United States

  • Fraser Eye Care Center

    Fraser, Michigan, 48026, United States

  • Guy's and St. Thomas NHS Trust

    London, SE1 7EH, United Kingdom

  • Hospital Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología

    Seville, 41071, Spain

  • Johannes Gutenberg-University Medical Center

    Mainz, 55131, Germany

  • KU Medical Center, University of Kansas

    Kansas City, Kansas, 66103, United States

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Med-Care Research Inc.

    Miami, Florida, 33125, United States

  • Miguel Servet University Hospital, Clinical Trials Unit

    Zaragoza, 50009, Spain

  • NZOZ E-Vita

    Bialystok, 15-879, Poland

  • Neuro-Eye Clinical Trials

    Houston, Texas, 77074, United States

  • Neuro-Ophthalmology of Texas, PLLC

    Houston, Texas, 77074, United States

  • New York Eye Ear Infirmary of Mount Sinai

    New York, New York, 10003, United States

  • North Shore Eye Surgery

    Sydney, 2065, Australia

  • Northwick Park Hospital

    London, HA1 3UJ, United Kingdom

  • Ophthalmic Consultants of Boston

    Weymouth, Massachusetts, 02189, United States

  • Panstwowy Instytut Medyczny MSWiA

    Warsaw, 02-507, Poland

  • Rutgers- New Jersey Medical School- Newark

    Newark, New Jersey, 07103, United States

  • Santa Familia PTG Lodz

    Lódz, 90-302, Poland

  • Sarasota Retina Institute

    Sarasota, Florida, 34231, United States

  • Sina Medical Center LLC

    Homestead, Florida, 33034, United States

  • Specjalistyczny Osrodek Okulistyczny Oculomedica

    Bydgoszcz, 85-870, Poland

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303, United States

  • Sydney Eye Hospital

    Sydney, 2000, Australia

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • University Health Diabetes, Endocrinology & Nephrology Center

    Kansas City, Kansas, 64108, United States

  • University of Colorado - Dept of Ophthalmology

    Aurora, Colorado, 80045, United States

  • University of Minnesota, Department of Ophthalmology and Visual Neurosciences

    Minneapolis, Minnesota, 55455, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Universitätsmedizin Göttingen

    Göttingen, 37075, Germany

  • Vision Medical Research Inc.

    Orland Park, Illinois, 60462, United States

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506, United States

  • Western Eye Hospital, Imperial College NHS Trust

    London, NW1 5QH, United Kingdom

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