A Phase 3 interventional study of VRDN-003 and Placebo in Thyroid Eye Disease (TED), sponsored by Viridian Therapeutics, Inc.. Active, not recruiting at 64 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Viridian Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.
191 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's enrollment of 320 is above the median of 64 across 142 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Viridian Therapeutics, Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
6 subcutaneous administrations of VRDN-003
Drug: VRDN-003
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Drug: VRDN-003 · Drug: Placebo
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Placebo injections that appear identical to VRDN-003 injections but have no active drug.
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Time frame: Week 24
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
Change from baseline in proptosis in the study eye
Time frame: Week 24
TEAE incident rate through study completion
Treatment Emergent Adverse Event (TEAE) incidence rate measurement through study completion
Time frame: Week 52
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Viridian Therapeutics, Inc.