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Safety and tolerability of VRDN-003 for Thyroid Eye Disease

A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Phase 3 Interventional Viridian Therapeutics, Inc. · NCT06812325

This study is testing a new drug called VRDN-003 to see if it's safe and helps people with Thyroid Eye Disease feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment284 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorViridian Therapeutics, Inc. Industry-sponsored
Locations18 sites (Tuscon, Arizona and 17 other locations)
Trial IDNCT06812325 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of an investigational drug, VRDN-003, in participants diagnosed with Thyroid Eye Disease (TED). It is a randomized, double-masked, controlled study that will assign participants to receive either VRDN-003 or a placebo through subcutaneous injections every 4 or 8 weeks. The study aims to determine the safety profile of VRDN-003 and its potential benefits for individuals suffering from TED, regardless of the duration of their condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a clinical diagnosis of Thyroid Eye Disease who may benefit from treatment with VRDN-003.

Not a fit: Patients who have received prior anti-IGF-1R therapy or other treatments for TED within specified timeframes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with Thyroid Eye Disease, potentially improving their quality of life.

How similar studies have performed: Other studies have explored treatments for Thyroid Eye Disease, but the specific approach of using VRDN-003 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

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 8 weeks prior to first dose
* Must not have received an investigational agent for any condition, including 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 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

Where this trial is running

Tuscon, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thyroid Eye DiseaseGravesThyroid-Associated OphthalmopathyDysthyroid OphthalmopathyGraves Eye DiseaseGraves OrbitopathyMyopathic OphthalmopathyCongestive Ophthalmopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.