A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants with Thyroid Eye Disease (TED)

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 treatment

• Must agree to use highly effective contraception method as specified in the protocol

• Female TED participants must have a negative serum pregnancy test

• Not require immediate ophthalmological or orbital surgery in the study eye for anyreason

Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R therapy

• Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1

• Must not have received rituximab, tocilizumab or other immunosuppressive agentswithin 8 weeks prior to Day 1

• Must not have received any other therapy for TED within 8 weeks prior to Day 1

• Must not have received an investigational agent for any condition within 8 weeksprior to the first dose of study medication

• Must not have a pre-existing ophthalmic condition in the study eye that in theopinion of the Investigator would confound interpretation of the study results

• Must not have had previous orbital irradiation or decompression surgery involvingexcision of fat for TED in the study eye's orbit

• Must not have inflammatory bowel disease

• Must not have abnormal hearing test before first dose. Must also not have a historyof ear conditions considered significant by study doctor.

• Must not have received an investigational agent for any condition within 8 weeksprior to Day 1

• Female TED participants must not be pregnant or lactating