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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2026 by Viridian Therapeutics, Inc.
Sponsor
Viridian Therapeutics, Inc.
Information Provided by (Responsible Party)
Viridian Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT06384547
Other Study ID Numbers:
VRDN-001-303
First Submitted
April 21, 2024
First Posted
April 24, 2024
Results First Posted
July 21, 2026
Last Update Posted
August 12, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Thyroid Eye Disease
Drug: VeligrotugDrug: Veligrotug

Study Design

Study TypeInterventional
Actual Enrollment231 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
Study Start DateMay 22, 2024
Actual Primary Completion DateApril 30, 2025
Actual Study Completion DateJanuary 18, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Veligrotug 10 mg/kg
Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks.
Drug: Veligrotug
5 infusions of veligrotug
Veligrotug 3 mg/kg
Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.
Drug: Veligrotug
5 infusions of veligrotug

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
    An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Secondary Outcome Measures
  1. Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer
    Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in millimeters (mm), measured using an exophthalmometer. Observed change from baseline in proptosis in study eye is reported. Missing data were not imputed.
  2. Number of Participants With TEAEs Through Week 52
    An AE was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment
Must agree to use highly effective contraception method as specified in the protocol
Female TED participants must have a negative serum pregnancy test at screening
Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
Exclusion Criteria
Must not have received prior treatment with another anti-IGF-1R therapy
Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
Must not have received any other therapy for TED within 8 weeks prior to Day 1
Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit
Must not have inflammatory bowel disease
Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor.
Female TED participants must not be pregnant or lactating.

Contacts and Locations

Sponsors and CollaboratorsViridian Therapeutics, Inc.
Locations
United Medical Research Institute | Inglewood California, United States, 90301Advancing Research International, LLC | Los Angeles California, United States, 90023Stanford Byers Eye Institute | Palo Alto California, United States, 94303Cockerham Eye Consultants, PC | San Diego California, United States, 92108FOMAT Medical Research | Santa Maria California, United States, 93454University of Colorado - Dept of Ophthalmology | Aurora Colorado, United States, 80045Sina Medical Center LLC | Homestead Florida, United States, 33034Med-Care Research Inc. | Miami Florida, United States, 33125Edward Jenner Research Group Center LLC | Plantation Florida, United States, 33317Sarasota Retina Institute | Sarasota Florida, United States, 34231Vision Medical Research Inc. | Orland Park Illinois, United States, 60462University Health Diabetes, Endocrinology & Nephrology Center | Kansas City Kansas, United States, 64108KU Medical Center, University of Kansas | Kansas City Kansas, United States, 66103Massachusetts Eye and Ear | Boston Massachusetts, United States, 02114Ophthalmic Consultants of Boston | Weymouth Massachusetts, United States, 02189Fraser Eye Care Center | Fraser Michigan, United States, 48026Kahana Oculoplastic & Orbital Surgery | Livonia Michigan, United States, 48152University of Minnesota, Department of Ophthalmology and Visual Neurosciences | Minneapolis Minnesota, United States, 55455Advancing Research International, LLC | Las Vegas Nevada, United States, 89144Rutgers- New Jersey Medical School- Newark | Newark New Jersey, United States, 07103New York Eye Ear Infirmary of Mount Sinai | New York New York, United States, 10003Baylor College of Medicine (BCM) - Ophthalmology | Houston Texas, United States, 77030Neuro-Eye Clinical Trials | Houston Texas, United States, 77074Neuro-Ophthalmology of Texas, PLLC | Houston Texas, United States, 77074University of Vermont Medical Center | Burlington Vermont, United States, 05401West Virginia University Eye Institute | Morgantown West Virginia, United States, 26506Sydney Eye Hospital | Sydney , Australia, 2000North Shore Eye Surgery | Sydney , Australia, 2065CHU d'Angers | Angers , France, 49100Centre Hospitalier National D'ophtalmologie | Des Quinze Vingts Paris , France, 75012CH Nice | Nice , France, 06000AP-HP - Hôpital de la Pitié Salpétrière | Paris , France, 75013Universitätsmedizin Göttingen | Göttingen , Germany, 37075Johannes Gutenberg-University Medical Center | Mainz , Germany, 55131NZOZ E-Vita | Bialystok , Poland, 15-879Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz , Poland, 85-870Santa Familia PTG Lodz | Lódz , Poland, 90-302Panstwowy Instytut Medyczny MSWiA | Warsaw , Poland, 02-5074 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ | Wroclaw , Poland, 53-114Clinica Bonanova de Cirugia Ocular | Barcelona , Spain, 08022Hospital Arruzafa | Córdoba , Spain, 14012Clínica Universidad de Navarra | Madrid , Spain, 28027Hospital Universitario Ramón y Cajal | Madrid , Spain, 28034Clinica Universidad de Navarra | Pamplona , Spain, 31008Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo | Santiago de Compostela, A Coruña , Spain, 15706Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología | Seville , Spain, 41071Miguel Servet University Hospital, Clinical Trials Unit | Zaragoza , Spain, 50009Northwick Park Hospital | London , United Kingdom, HA1 3UJWestern Eye Hospital, Imperial College NHS Trust | London , United Kingdom, NW1 5QHGuy's and St. Thomas NHS Trust | London , United Kingdom, SE1 7EH
Study Documents (Full Text)
Documents provided by Viridian Therapeutics, Inc.: Study Protocol  May 5, 2024Documents provided by Viridian Therapeutics, Inc.: Statistical Analysis Plan  February 5, 2026