A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )

Key Inclusion Criteria for Active TED Participants (THRIVE):

• Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening

• Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye

• 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 for Active TED Participants (THRIVE):

• Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED

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

• Must not have received rituximab, tocilizumab or other immunosuppressive agents or any other therapy for TED within 8 weeks prior to Day 1

• Must not have received an investigational agent for any condition with 8 weeks prior to Day 1

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

• Must not have had previous orbital irradiation or surgery for TED in the study eye

• Must not have a history of inflammatory bowel disease

• Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss

• Female TED participants must not be pregnant or lactating

Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.