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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified September 2025 by Viridian Therapeutics, Inc.
Sponsor
Viridian Therapeutics, Inc.
Information Provided by (Responsible Party)
Viridian Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT06021054
Other Study ID Numbers:
VRDN-001-301
First Submitted
August 24, 2023
First Posted
August 31, 2023
Last Update Posted
October 22, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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

Condition or DiseaseIntervention/Treatment
Thyroid Eye Disease
Drug: Veligrotug (VRDN-001)Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment188 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateNovember 13, 2023
Actual Primary Completion DateNovember 3, 2024
Actual Study Completion DateJuly 24, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Veligrotug (VRDN-001)10 mg/kg
Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg
Drug: Veligrotug (VRDN-001)
Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor
Placebo Drug
Placebo Drug: 5 IV Infusions of placebo
Drug: Placebo
5 IV infusions of placebo

Outcome Measures

Primary Outcome Measures
  1. Proptosis Responder Rate in the most proptotic eye
    Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥2 mm from baseline \[without a corresponding increase of ≥2 mm in the other eye\]) as measured by exophthalmometer.
Secondary Outcome Measures
  1. Change from baseline in proptosis in the most proptotic eye
    Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
  2. Proptosis Responder Rate in the most proptotic eye
    Change from baseline in proptosis in the most proptotic eye
  3. Clinical Activity Responder Rate in the most proptotic eye
    Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline \[without a corresponding increase of ≥2 points in the other eye\]) as measured by exophthalmometer
  4. Overall Responder Rate in the most proptotic eye
    Overall Responder Rate comprised of Proptosis Responder Rate in the most proptotic eye as measured by exophthalmometer and Clinical Activity Responder rate in the most proptotic eye as measured by exophthalmometer
  5. Diplopia Responder Rate
    Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)
  6. Diplopia Resolution Rate
    Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score \> 0)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
Must have had a clinical diagnosis of TED, with any CAS (0-7)
Must agree to use highly effective contraception as specified in the protocol
Female TED participants must have a negative serum pregnancy test at screening Key
Exclusion Criteria
Must not have received prior treatment with another anti-IGF-1R therapy
Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose
Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results
Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
Must not have inflammatory bowel disease
Have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss.
Female TED participants must not be pregnant or lactating

Contacts and Locations

Sponsors and CollaboratorsViridian Therapeutics, Inc.
Locations
Advancing Research International, LLC | Los Angeles California, United States, 90023USC Roski Eye Institute | Los Angeles California, United States, 90089Amy Patel Jain, MD | Newport Beach California, United States, 92660Stanford Byers Eye Institute | Palo Alto California, United States, 94303Cockerham Eye Consultants, PC | San Diego California, United States, 92108Bascom Palmer Eye Institute - Ophthalmology - Miami | Miami Florida, United States, 33136Sarasota Retina Institute | Sarasota Florida, United States, 34239Northwestern University | Chicago Illinois, United States, 60611Family Eye Physicians, Ltd | Oak Lawn Illinois, United States, 60453Massachusetts Eye and Ear | Boston Massachusetts, United States, 02114Ophthalmic Consultants of Boston | Boston Massachusetts, United States, 02189Michigan State University, Department of Neurology | East Lansing Michigan, United States, 48824Kahana Oculoplastic and Orbital Surgery | Livonia Michigan, United States, 48152Washington University School of Medicine in St Louis - Ophthalmology | St Louis Missouri, United States, 63110Steven Leibowitz, MD. | Las Vegas Nevada, United States, 89144Rutgers - New Jersey Medical School | Newark New Jersey, United States, 07103The Center for Eye and Facial Plastic Surgery | Somerset New Jersey, United States, 08873Department of Ophthalmology, University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Wills Eye Hospital | Philadelphia Pennsylvania, United States, 19107Baylor College of Medicine (BCM) - Ophthalmology | Houston Texas, United States, 77030Neuro Eye Clinical Trials | Houston Texas, United States, 77074University of Vermont Medical Center | Burlington Vermont, United States, 05401Harborview Medical Center | Seattle Washington, United States, 98104North Shore Private Hospital | Saint Leonards New South Wales, Australia, 2065CHU Angers | Angers , France, 49033CHU de Bordeaux - Hôpital Saint-André | Bordeaux , France, 33000Centre Hospitalier Universitaire De Nantes - G. R. Laennec | Nantes , France, 44093CH Nice | Nice , France, 06000Charité - Universitätsmedizin Berlin KöR | Berlin , Germany, 13353Universitätsklinikum Essen AöR | Essen , Germany, 45122University Medical Center Freiburg | Freiburg im Breisgau , Germany, 79106Universitätsmedizin Göttingen | Göttingen , Germany, 37075Budapest Retina Intezet | Budapest , Hungary, H-1133Ganglion Orvosi Kozpont | Pécs , Hungary, H-7621Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika | Pécs , Hungary, H-7623Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok , Poland, 15-276Oculomedica Sp. z o.o. | Bialystok , Poland, 85-157Optimum Profesorskie Centrum Okulistyki Sp. z o.o. | Gdansk , Poland, 80-809Centrum Medyczne Pulawska Sp. z o.o. | Piaseczno , Poland, 05-500Centrum Medyczne Piasta 47 sp. z o.o. | Wałbrzych , Poland, 58-304Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo | A Coruña , Spain, 15706Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre) | Barcelona , Spain, 08021Hospital La Arruzafa | Córdoba , Spain, 14012Hospital Universitario Ramón y Cajal | Madrid , Spain, 28034Hospital Universitario Virgen De La Macarena | Seville , Spain, 41009Hospital Universitario Virgen del Rocio | Seville , Spain, 41013Hospital Universitario Y Politécnico La Fe | Valencia , Spain, 46026Hospital Unviersitario Miguel Servet | Zaragoza , Spain, 50009Hacettepe Universitesi Tip Fakultesi | Ankara , Turkey (Türkiye), 06230Gazi University Medical Faculty Hospital | Ankara , Turkey (Türkiye), 06500Akdeniz University Medical Faculty Hospital | Antalya , Turkey (Türkiye), 07059Marmara University Faculty of Medicine | Istanbul , Turkey (Türkiye), 34854Moorfield's Eye Hospital | London , United Kingdom, EC1V 2PDImperial College Healthcare NHS Trust - Western eye Hospital | London , United Kingdom, NW1 5QHGuy's and St. Thomas NHS Trust | London , United Kingdom, SE1 7EHThe Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle , United Kingdom, NEI 4LPUniversity Hospital Southampton NHS Foundation Trust | Southampton , United Kingdom, SO16 6YD