A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )
Completed · Phase 3 · Has a placebo group
Conditions studied: Thyroid Eye Disease
In brief
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.
Key facts
- Study ID
- NCT05176639
- Run by
- Viridian Therapeutics, Inc.
- People needed
- 113
- Starts
- 2021-12-03
- Expected to finish
- 2025-03-27
- Last updated by the study team
- 2025-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- North Shore Eye Surgery — Sydney, Australia
- University of Colorado - Department of Ophthalmology — Aurora, California, United States
- The Private Office of Raymond Douglas — Beverly Hills, California, United States
- USC Roski Eye Institute — Los Angeles, California, United States
- MACRO Trials, Inc. — Los Angeles, California, United States
- Amy Patel Jain, MD — Newport Beach, California, United States
- Byers Eye Institute/Stanford University — Palo Alto, California, United States
- Senta Clinic — San Diego, California, United States
- University of California, San Francisco — San Francisco, California, United States
- University of Colorado — Aurora, Colorado, United States
- Sina Medical Center — Homestead, Florida, United States
- Med-Care Research Inc. — Miami, Florida, United States
- Edward Jenner Research Group Center LLC — Plantation, Florida, United States
- Sarasota Retina Institue — Sarasota, Florida, United States
- Vision Medical Research Inc. — Orland Park, Illinois, United States
- University Health Diabetes, Endocrinology & Nephrology Center — Kansas City, Kansas, United States
- KU Medical Center, University of Kansas — Kansas City, Kansas, United States
- Massachusetts Eye and Ear — Boston, Massachusetts, United States
- Ophthalmic Consultants of Boston — Weymouth, Massachusetts, United States
- Fraser Eye Care Center — Fraser, Michigan, United States
- Kahana Oculoplastic & Orbital Surgery — Livonia, Michigan, United States
- University of Minnesota, Department of Ophthalmology and Visual Neurosciences — Minneapolis, Minnesota, United States
- Advanced Research International, LLC — Las Vegas, Nevada, United States
- Rutgers-New Jersey Medical School-Newark — Newark, New Jersey, United States
- Sydney Eye Hospital — Sydney, Australia
Full record on ClinicalTrials.gov
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