NCT06021054

An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)

A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Viridian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

Detailed description

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), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	Veligrotug (VRDN-001)	Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor
DRUG	Placebo	5 IV infusions of placebo

Timeline

• Start date: 2023-11-14
• Primary completion: 2024-11-04
• Completion: 2025-07-25
• First posted: 2023-09-01
• Last updated: 2025-10-23

Locations

57 sites across 9 countries: United States, Australia, France, Germany, Hungary, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study