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

NCT06384547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-08-13

Study results available
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Summary

The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.

Conditions

Interventions

DRUG

Veligrotug

5 infusions of veligrotug

Sponsors & Collaborators

  • Viridian Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2025-05-01
Completion
2026-01-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384547 on ClinicalTrials.gov