NCT05176639

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

A Multiple Ascending Dose (MAD) Safety, Tolerability and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Normal Healthy Volunteers (NHV(s) and Subjects With Thyroid Eye Disease (TED)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Viridian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigational drug, veligrotug (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 patients with thyroid eye disease (TED). The primary objective of this clinical trial is to establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	VRDN-001 Phase 3 Cohort (THRIVE)	5 IV Infusions of veligrotug (VRDN-001) 10mg/kg
DRUG	VRDN-001 Placebo	5 IV Infusions of veligrotug (VRDN-001) placebo

Timeline

• Start date: 2021-12-03
• Primary completion: 2024-07-15
• Completion: 2025-03-27
• First posted: 2022-01-04
• Last updated: 2025-07-18

Locations

53 sites across 7 countries: United States, Australia, France, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study