Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05176639 · ClinicalTrials.gov registry record · Phase 3
A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )
A Phase 3 study of Thyroid Eye Disease, sponsored by Viridian Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT05176639: Completed Phase 3 study of Thyroid Eye Disease, sponsored by Viridian Therapeutics.
NCT05176639 is a Phase 3 study of Thyroid Eye Disease that has completed, run by Viridian Therapeutics. The registered enrollment target is 113 participants, above the 99-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05176639, a Phase 3 study of Thyroid Eye Disease, has completed, sponsored by Viridian Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Proptosis responder in the study eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the study eye (without a corresponding increase of ≥2 mm in the fellow eye) as measured by exophthalmometer. Missing data were imputed with the Multiple Imputation method.
Conditions Studied
Interventions
- DRUG VRDN-001 Phase 3 Cohort (THRIVE)
- DRUG VRDN-001 Placebo
Study Locations (20)
California
- University of Colorado - Department of Ophthalmology - Aurora
- The Private Office of Raymond Douglas - Beverly Hills
- USC Roski Eye Institute - Los Angeles
- MACRO Trials, Inc. - Los Angeles
- Amy Patel Jain, MD - Newport Beach
- Byers Eye Institute/Stanford University - Palo Alto
- Senta Clinic - San Diego
- University of California, San Francisco - San Francisco
Florida
- Sina Medical Center - Homestead
- Med-Care Research Inc. - Miami
- Edward Jenner Research Group Center LLC - Plantation
- Sarasota Retina Institue - Sarasota
Kansas
- University Health Diabetes, Endocrinology & Nephrology Center - Kansas City
- KU Medical Center, University of Kansas - Kansas City
Massachusetts
- Massachusetts Eye and Ear - Boston
- Ophthalmic Consultants of Boston - Weymouth
Michigan
- Fraser Eye Care Center - Fraser
- Kahana Oculoplastic & Orbital Surgery - Livonia
Colorado
- University of Colorado - Aurora
Illinois
- Vision Medical Research Inc. - Orland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2025-03-27 |
| Phase | Phase 3 |
What the finished NCT05176639 record still lists
NCT05176639 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which VRDN-001 Phase 3 Cohort (THRIVE) is the first listed.
NCT05176639 names 20 study sites across 7 states, led by California, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT05176639 about?
NCT05176639 is a clinical study titled "A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )". 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 ...
What is the current status of trial NCT05176639?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2021-12-03. Estimated completion is 2025-03-27.
What conditions does trial NCT05176639 study?
This clinical trial studies the following conditions: Thyroid Eye Disease.
What interventions are being tested in trial NCT05176639?
The interventions under investigation include: VRDN-001 Phase 3 Cohort (THRIVE) (DRUG), VRDN-001 Placebo (DRUG).
Who is sponsoring clinical trial NCT05176639?
This trial is sponsored by Viridian Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05176639 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Thyroid Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05176639's enrollment target sits among peer trials
113 6th of 15 higher than 10 of 15 other Thyroid Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thyroid Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
-
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00748254 · 113 participants
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis
- NCT04753190 · 113 participants · NA
Light Timing Study
- NCT05799248 · 113 participants · Phase 3
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- NCT07216105 · 113 participants · Phase 1
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI