A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Completed · Phase 3

Conditions studied: Thyroid Eye Disease

In brief

This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

Key facts

Study ID

NCT07155668

Run by

Viridian Therapeutics, Inc.

People needed

87

Starts

2025-07-01

Expected to finish

2026-05-28

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• United Medical Research Institute — Inglewood, California, United States
• C&A Clinical Trials Corp — Cape Coral, Florida, United States
• Ilumina Medical Research — Kissimmee, Florida, United States
• Med-Care Research — Miami, Florida, United States
• Continental Clinical Research, llc — Miami, Florida, United States
• Hype Clinical Research, LLC — Miami, Florida, United States
• Advanced Quality Medical Research, LLC — Orland Park, Illinois, United States
• Ophthalmic Consultants of Boston — East Weymouth, Massachusetts, United States
• Fraser Eye Center — Fraser, Michigan, United States
• Kahana Oculoplastic and Orbital Surgery — Livonia, Michigan, United States
• Vector Clinical Trials — Sparks, Nevada, United States
• Baylor College of Medicine, Alkek Eye Center — Houston, Texas, United States
• Neuro Eye Clinical Trials INC — Houston, Texas, United States

Full record on ClinicalTrials.gov

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