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Thyroid Eye DiseasePhase 3THRIVE-2NCT06021054

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

A Phase 3 study testing Veligrotug in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 57 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thyroid Eye Disease
What is being tested?
Veligrotug
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
57 sitesin 9 countries
Study dates
1 Nov 2023to 25 Jul 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Must not have inflammatory bowel disease
  • Must not 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

Trial locations and contacts

57 sites in 9 countries.

57 sites in 9 countries

United States23 sites

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02189

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Northwestern University

    Chicago, Illinois, 60611

  • Michigan State University, Department of Neurology

    East Lansing, Michigan, 48824

  • Baylor College of Medicine (BCM) - Ophthalmology

    Houston, Texas, 77030

  • Neuro Eye Clinical Trials

    Houston, Texas, 77074

  • Steven Leibowitz, MD.

    Las Vegas, Nevada, 89144

  • Kahana Oculoplastic and Orbital Surgery

    Livonia, Michigan, 48152

  • Advancing Research International, LLC

    Los Angeles, California, 90023

  • USC Roski Eye Institute

    Los Angeles, California, 90089

  • Bascom Palmer Eye Institute - Ophthalmology - Miami

    Miami, Florida, 33136

  • Rutgers - New Jersey Medical School

    Newark, New Jersey, 07103

  • Amy Patel Jain, MD

    Newport Beach, California, 92660

  • Family Eye Physicians, Ltd

    Oak Lawn, Illinois, 60453

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303

  • Department of Ophthalmology, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Cockerham Eye Consultants, PC

    San Diego, California, 92108

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Harborview Medical Center

    Seattle, Washington, 98104

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey, 08873

  • Washington University School of Medicine in St Louis - Ophthalmology

    St Louis, Missouri, 63110

Other trials in United States

Spain8 sites

  • Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo

    A Coruña, 15706

  • Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)

    Barcelona, 08021

  • Hospital La Arruzafa

    Córdoba, 14012

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026

  • Hospital Unviersitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Poland5 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Oculomedica Sp. z o.o.

    Bialystok, 85-157

  • Optimum Profesorskie Centrum Okulistyki Sp. z o.o.

    Gdansk, 80-809

  • Centrum Medyczne Pulawska Sp. z o.o.

    Piaseczno, 05-500

  • Centrum Medyczne Piasta 47 sp. z o.o.

    Wałbrzych, 58-304

Other trials in Poland

United Kingdom5 sites

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Imperial College Healthcare NHS Trust - Western eye Hospital

    London, NW1 5QH

  • St. Thomas' Hospital

    London, SE1 7EH

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NEI 4LP

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

France4 sites

  • CHU Angers

    Angers, 49033

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000

  • Centre Hospitalier Universitaire De Nantes - G. R. Laennec

    Nantes, 44093

  • CH Nice

    Nice, 06000

Other trials in France

Germany4 sites

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 13353

  • Universitätsklinikum Essen AöR

    Essen, 45122

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Göttingen

    Göttingen, 37075

Other trials in Germany

Turkey (Türkiye)4 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Gazi University Medical Faculty Hospital

    Ankara, 06500

  • Akdeniz University Medical Faculty Hospital

    Antalya, 07059

  • Marmara University Faculty of Medicine

    Istanbul, 34854

Other trials in Turkey (Türkiye)

Hungary3 sites

  • Budapest Retina Intezet

    Budapest, H-1133

  • Ganglion Orvosi Kozpont

    Pécs, H-7621

  • Pecsi Tudomanyegyetem Klinikai Kozpont Szemeszeti Klinika

    Pécs, H-7623

Other trials in Hungary

Australia1 site

  • North Shore Private Hospital

    Saint Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official title: A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

Read the detailed 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.

Being tested
Veligrotug, Placebo
Keywords
Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy, TED, Thyroid-Associated Orbitopathy, Graves Disease
Medical subject headings
Graves Ophthalmopathy, Graves Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeligrotugDrug

    Also called VRDN-001

    5 IV Infusions of veligrotug 10 mg/kg

  • PlaceboDrug

    5 IV Infusions of veligrotug matched placebo

Study groups in NCT06021054
Study groupRoleWhat they receive
VeligrotugExperimentalParticipants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.
Receives: Drug: Veligrotug
PlaceboExperimentalParticipants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer

    Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were imputed with the Multiple Imputation (MI) method.

    Measured: Baseline to Week 15

Secondary outcomes (7)

  1. Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer

    Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in mm, measured using an exophthalmometer. Missing data were imputed with the MI method.

    Measured: Baseline, Week 15

  2. PRR in the Most Proptotic Eye, as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)

    Proptosis responder in the most proptotic eye by MRI/CT was defined as a reduction of proptosis of ≥2 mm from baseline in the most proptotic eye by MRI/CT (without a corresponding increase of ≥2 mm in the other eye) as measured by MRI/CT. Missing data were imputed using the Exophthalmometer Imputation (EXI) method, as applicable.

    Measured: Baseline to Week 15

  3. Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT

    Measurement of proptosis was conducted by the central imaging reading center using MRI/CT of the orbits acquired without contrast. Measurements were conducted by 2 independent readers with adjudication if the difference between the 2 primary readers in proptosis measurement exceeded 5% (calculated as the difference divided by the larger measurement). The average of 2 (or 3 if adjudicated) measurements were used for analyses. Missing data were imputed using the EXI method, as applicable.

    Measured: Baseline, Week 15

  4. Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

    Clinical activity responder in the most proptotic eye was defined as no worsening in clinical activity score (CAS) from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye. Missing data were imputed with the MI method.

    Measured: Week 15

  5. Overall Responder Rate (ORR) Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer

    ORR was comprised of PRR in the most proptotic eye (reduction of proptosis of ≥2 mm from baseline in the most proptotic eye [without a corresponding increase of ≥2 mm in the other eye]) as measured by exophthalmometer at Week 15 and Clinical Activity Responder rate in the most proptotic eye (no worsening in CAS from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye) as measured by exophthalmometer at Week 15. Missing data were imputed with the MI method.

    Measured: Baseline to Week 15

  6. Diplopia Responder Rate

    A diplopia responder was defined as having a decrease of ≥1 from baseline for participants with a baseline Gorman subjective diplopia score >0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

    Measured: Week 15

  7. Diplopia Resolution Rate

    Diplopia resolution was defined as reduction in Gorman subjective diplopia score to 0 from baseline for participants with baseline Gorman subjective diplopia score >0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

    Measured: Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion4 Nov 2024
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021054
Sponsor's protocol ID
VRDN-001-301
Acronym
THRIVE-2
Status last verified
Jul 2026
First submitted
25 Aug 2023
Last updated
13 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Veligrotug in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 57 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Spain, Poland, United Kingdom, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer (time frame: Baseline to Week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06021054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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