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New shot for bulging eyes shows promise in early trial

NCT ID NCT07155668

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new drug called VRDN-003 in 87 people with thyroid eye disease (TED). The drug is given as a shot under the skin and targets a protein linked to the disease. The main goal was to check safety and how the drug moves through the body, not yet to measure how well it treats symptoms.

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 targeting IGF-1 receptor)
What this could lead to
If successful, this could lead to a new treatment option for thyroid eye disease that is given as a simple injection under the skin.
What could go wrong
This is an early-phase study focused on safety and drug levels, not yet on how well it works. The drug may not prove effective in larger trials or could have side effects.

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

87 people

The number who actually took part.

Started

Jul 2025

Finished

May 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, 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 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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

Contacts and locations

Locations

  • Advanced Quality Medical Research, LLC

    Orland Park, Illinois, 60462, United States

  • Baylor College of Medicine, Alkek Eye Center

    Houston, Texas, 77030, United States

  • C&A Clinical Trials Corp

    Cape Coral, Florida, 33990, United States

  • Continental Clinical Research, llc

    Miami, Florida, 33144, United States

  • Fraser Eye Center

    Fraser, Michigan, 48026, United States

  • Hype Clinical Research, LLC

    Miami, Florida, 33145, United States

  • Ilumina Medical Research

    Kissimmee, Florida, 34744, United States

  • Kahana Oculoplastic and Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Med-Care Research

    Miami, Florida, 33125, United States

  • Neuro Eye Clinical Trials INC

    Houston, Texas, 77074, United States

  • Ophthalmic Consultants of Boston

    East Weymouth, Massachusetts, 02189, United States

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • Vector Clinical Trials

    Sparks, Nevada, 89128, United States

More trials for these conditions

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