Thyroid Eye DiseasePhase 3THRIVENCT05176639
A Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN 001) in Participants With Thyroid Eye Disease (TED)
A Phase 3 study testing Veligrotug in people with Thyroid Eye Disease, run by Viridian Therapeutics, Inc. at 53 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 113 participants
- Where
- 53 sitesin 7 countries
- Study dates
- 16 Nov 2022to 27 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Inclusion Criteria for Active TED Participants (THRIVE):
- Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
- Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
- 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 for Active TED Participants (THRIVE):
- Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
- 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 or 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 Day 1
- 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 surgery for TED in the study eye
- Must not have a history of inflammatory bowel disease
- Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
- Female TED participants must not be pregnant or lactating
Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
United States29 sites
University of Colorado - Department of Ophthalmology
Aurora, California, 80045
University of Colorado
Aurora, Colorado, 80045
The Private Office of Raymond Douglas
Beverly Hills, California, 90210
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
Fraser Eye Care Center
Fraser, Michigan, 48026
Sina Medical Center
Homestead, Florida, 33034
Baylor College of Medicine (BCM)-Ophthalmology
Houston, Texas, 77030
Neuro-Eye Clinical Trials
Houston, Texas, 77074
Neuro-Ophthalmology of Texas PLLC
Houston, Texas, 77074
University Health Diabetes, Endocrinology & Nephrology Center
Kansas City, Kansas, 64108
KU Medical Center, University of Kansas
Kansas City, Kansas, 66103
Advanced Research International, LLC
Las Vegas, Nevada, 89144
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
USC Roski Eye Institute
Los Angeles, California, 90033
MACRO Trials, Inc.
Los Angeles, California, 90049
Med-Care Research Inc.
Miami, Florida, 33125
University of Minnesota, Department of Ophthalmology and Visual Neurosciences
Minneapolis, Minnesota, 55455
West Virgina University Eye Institute
Morgantown, West Virginia, 26506
New York Eye Ear Infirmary of Mount Sinai
New York, New York, 10003
Rutgers-New Jersey Medical School-Newark
Newark, New Jersey, 07103
Amy Patel Jain, MD
Newport Beach, California, 92260
Vision Medical Research Inc.
Orland Park, Illinois, 60462
Byers Eye Institute/Stanford University
Palo Alto, California, 94303
Edward Jenner Research Group Center LLC
Plantation, Florida, 33317
Senta Clinic
San Diego, California, 95207
University of California, San Francisco
San Francisco, California, 94158
Sarasota Retina Institute
Sarasota, Florida, 34231
Ophthalmic Consultants of Boston
Weymouth, Massachusetts, 02189
Spain8 sites
Clinica Bonanova de Cirugia Ocular
Barcelona, 08022
Hospital Arruzafa
Córdoba, 14012
Clinica Universidad de Navarra
Madrid, 28027
Hospital Universitario Ramon y Cajal
Madrid, 28034
Clinica Universidad de Navarra
Pamplona, 31008
Complexo Hospiralario Universitario de Santiago-Hospital Medico-Ciruxico de Conxo
Santiago, 15706
Hospital Universitatio Virgen De La Macarena, Servicio de Oftalmologia
Seville, 41071
Hospital Universitario Miguel Servet, Servicio de Paseo Isabel La Catdlica1
Zaragoza, 50009
Poland5 sites
NZOZ E-Vita
Bialystok, 15-879
Specjakistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-870
Santa Familia PTG Lodz
Lodz, 90-302
Panstwowy Instytut Medycsny MSWiA
Warsaw, 02-507
4 Wojskowy Szpital Kliniczny z Polikinika SP ZOZ
Wroclaw, 53-114
France4 sites
CHU d'Angers
Angers, 49100
CH Nice
Nice, 06000
Centre Hospitalier National D'ophtalmologie
Paris, 75012
AP-HP- Hopital de la Pitie Salpetriere
Paris, 75013
United Kingdom3 sites
Northwick Park Hospital
London, United Kingdon, HA13UJ
Western Eye Hospital Imperial College NHS trust
London, United Kingdon, NW1 5QH
Guy's and St. Thomas NHS Trust
London, United Kingdon, SE1 7EH
Australia2 sites
Sydney Eye Hospital
Sydney, 2000
North Shore Eye Surgery
Sydney, 2065
Germany2 sites
Universitatsmedizin Gottingen
Göttingen, 37075
Johannes Gutenberg-University Medical Center
Mainz, 55131
About this study
Official title: A Safety, Tolerability, and Efficacy Study of Veligrotug, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor in Subjects With Thyroid Eye Disease
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 participants 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 participants who received 10 milligrams (mg)/kilogram (kg).
- Conditions
- Thyroid Eye Disease
- 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, 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 group | Role | What they receive |
|---|---|---|
| Veligrotug | Experimental | Participants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks. Receives: Drug: Veligrotug |
| Placebo | Placebo comparator | Participants 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.
Proptosis Responder Rate (PRR) in the Study Eye As Measured by Exophthalmometer
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.
Measured: Baseline to Week 15
Secondary outcomes (9)
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 mm, measured using an exophthalmometer. Missing data were imputed with the Multiple Imputation method.
Measured: Baseline, Week 15
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 method, as applicable.
Measured: Week 15
Change From Baseline in Proptosis in the Most Proptotic Eye As Measured by MRI/CT
Measurement of proptosis 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 Exophthalmometer Imputation method, as applicable.
Measured: Baseline, Week 15
Change From Baseline in CAS in the Study Eye
The CAS was based on 7 components: spontaneous retrobulbar pain, pain on attempted eye movements (upward, side to-side, and downward gazes), conjunctival redness, redness of the eyelids, chemosis, swelling of the caruncle or plica and swelling of the eyelids. Each component was scored as present or absent (scored as 1 or 0, respectively), and the CAS was given as the sum of the scores (range, 0 to 7, with higher scores indicating greater level of inflammation). Missing data were imputed with the Multiple Imputation method.
Measured: Baseline, Week 15
Overall Responder Rate (ORR) Comprising of PRR and Clinical Activity Responder Rate in the Study Eye
ORR in the study eye was comprised of PRR in the study eye (reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye]) and clinical activity responder in the study eye (reduction in clinical activity score [CAS] ≥ 2 points from baseline [without a corresponding increase of ≥ 2 points in the fellow eye]). CAS ranged from 0 to 7, with higher scores indicating greater level of inflammation. Proptosis (distance between the lateral orbital rim and the most anterior position of the cornea in mm) was measured using an exophthalmometer. Missing data were imputed with Multiple Imputation method.
Measured: Baseline to Week 15
Clinical Activity Responder Rate in the Study Eye
Clinical activity responder rate in the study eye was defined as a reduction in CAS ≥2 points from baseline in the study eye (without a corresponding increase of ≥2 points in the fellow eye). Missing data were imputed with the Multiple Imputation method.
Measured: Week 15
Diplopia Responder Rate
Diplopia responder was defined as reduction in Gorman subjective diplopia score of ≥1 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 Multiple Imputation method.
Measured: Week 15
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 Multiple Imputation method.
Measured: Week 15
Percentage of Participants With a CAS of 0 or 1 in the Study Eye
The CAS was based on 7 components: spontaneous retrobulbar pain, pain on attempted eye movements (upward, side to-side, and downward gazes), conjunctival redness, redness of the eyelids, chemosis, swelling of the caruncle or plica and swelling of the eyelids. Each component was scored as present or absent (scored as 1 or 0, respectively), and the CAS was given as the sum of the scores (range, 0 to 7, with higher scores indicating greater level of inflammation). Missing data were imputed with the Multiple Imputation 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.
- First posted4 Jan 2022
- Study start16 Nov 2022
- Primary completion15 Jul 2024
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viridian Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176639
- Sponsor's protocol ID
- VRDN-001-101
- Acronym
- THRIVE
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2021
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, and Efficacy Study of Veligrotug, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor in Subjects With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT05176639
- Acronym / sponsor ID
- THRIVE / VRDN-001-101
- Conditions
- Thyroid Eye Disease
- Keywords
- Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Viridian Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participants 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 participants who received 10 milligrams (mg)/kilogram (kg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veligrotug | Experimental | Drug: VeligrotugParticipants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeligrotugAlso: VRDN-0015 IV Infusions of veligrotug 10 mg/kg | Drug | Veligrotug |
| Placebo5 IV Infusions of veligrotug matched placebo | Drug | Placebo |
Primary outcome
Proptosis Responder Rate (PRR) in the Study Eye As Measured by Exophthalmometer
Time frame: Baseline to Week 15
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.
9 secondary outcomes
Change From Baseline in Proptosis in the Study Eye As Measured by Exophthalmometer
Time frame: Baseline, Week 15
PRR in the Most Proptotic Eye As Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)
Time frame: Week 15
Change From Baseline in Proptosis in the Most Proptotic Eye As Measured by MRI/CT
Time frame: Baseline, Week 15
Change From Baseline in CAS in the Study Eye
Time frame: Baseline, Week 15
Overall Responder Rate (ORR) Comprising of PRR and Clinical Activity Responder Rate in the Study Eye
Time frame: Baseline to Week 15
Clinical Activity Responder Rate in the Study Eye
Time frame: Week 15
Diplopia Responder Rate
Time frame: Week 15
Diplopia Resolution Rate
Time frame: Week 15
Percentage of Participants With a CAS of 0 or 1 in the Study Eye
Time frame: Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 7 countries: see every site and its status.
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 53 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 53 sites in United States, Spain, Poland, France, United Kingdom and 2 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. Some participants in this study may receive a placebo. 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 Study 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?
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.