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New antibody drug shows promise for bulging eyes in thyroid disease

NCT ID NCT06021054

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This Phase 3 trial tested an investigational drug called veligrotug (VRDN-001) in 188 people with chronic thyroid eye disease. The drug is an antibody that blocks a protein involved in the disease. The main goal was to see if it could reduce eye bulging (proptosis) compared to a placebo. The study is now complete, and results will show if this treatment is safe and effective.

What this could mean

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

Active substance
veligrotug (VRDN-001), a lab-made antibody that blocks a protein called IGF-1 receptor
What this could lead to
If it works, this could offer a new treatment option for people with chronic thyroid eye disease, helping reduce eye bulging and discomfort.
What could go wrong
This is a Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. It is also only for people with long-standing disease, not early cases.

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

188 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2025

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: * Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening * Must have had a clinical diagnosis of TED, with any CAS (0-7) * 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 for any condition, including TED, or selenium within 2 weeks prior to first dose * Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose * Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit * Must not have inflammatory bowel disease * Must not have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss. * 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

  • Advancing Research International, LLC

    Los Angeles, California, 90023, United States

  • Akdeniz University Medical Faculty Hospital

    Antalya, 07059, Turkey (Türkiye)

  • Amy Patel Jain, MD

    Newport Beach, California, 92660, United States

  • Bascom Palmer Eye Institute - Ophthalmology - Miami

    Miami, Florida, 33136, United States

  • Baylor College of Medicine (BCM) - Ophthalmology

    Houston, Texas, 77030, United States

  • Budapest Retina Intezet

    Budapest, H-1133, Hungary

  • CH Nice

    Nice, 06000, France

  • CHU Angers

    Angers, 49033, France

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire De Nantes - G. R. Laennec

    Nantes, 44093, France

  • Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)

    Barcelona, 08021, Spain

  • Centrum Medyczne Piasta 47 sp. z o.o.

    Wałbrzych, 58-304, Poland

  • Centrum Medyczne Pulawska Sp. z o.o.

    Piaseczno, 05-500, Poland

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 13353, Germany

  • Cockerham Eye Consultants, PC

    San Diego, California, 92108, United States

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

    A Coruña, 15706, Spain

  • Department of Ophthalmology, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Family Eye Physicians, Ltd

    Oak Lawn, Illinois, 60453, United States

  • Ganglion Orvosi Kozpont

    Pécs, H-7621, Hungary

  • Gazi University Medical Faculty Hospital

    Ankara, 06500, Turkey (Türkiye)

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Hospital La Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026, Spain

  • Hospital Unviersitario Miguel Servet

    Zaragoza, 50009, Spain

  • Imperial College Healthcare NHS Trust - Western eye Hospital

    London, NW1 5QH, United Kingdom

  • Kahana Oculoplastic and Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Marmara University Faculty of Medicine

    Istanbul, 34854, Turkey (Türkiye)

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Michigan State University, Department of Neurology

    East Lansing, Michigan, 48824, United States

  • Moorfields Eye Hospital

    London, EC1V 2PD, United Kingdom

  • Neuro Eye Clinical Trials

    Houston, Texas, 77074, United States

  • North Shore Private Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oculomedica Sp. z o.o.

    Bialystok, 85-157, Poland

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02189, United States

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

    Gdansk, 80-809, Poland

  • Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika

    Pécs, H-7623, Hungary

  • Rutgers - New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • St. Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303, United States

  • Steven Leibowitz, MD.

    Las Vegas, Nevada, 89144, United States

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey, 08873, United States

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NEI 4LP, United Kingdom

  • USC Roski Eye Institute

    Los Angeles, California, 90089, United States

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Universitätsklinikum Essen AöR

    Essen, 45122, Germany

  • Universitätsmedizin Göttingen

    Göttingen, 37075, Germany

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • Washington University School of Medicine in St Louis - Ophthalmology

    St Louis, Missouri, 63110, United States

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107, United States

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