Thyroid Eye Disease, TEDPhase 3ORBITNCT07753603
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
A Phase 3 study testing linsitinib in people with Thyroid Eye Disease, TED and Graves Orbitopathy, run by Sling Therapeutics, Inc. at 18 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, TED, Graves Orbitopathy
- What is being tested?
- linsitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 18 sitesUnited States
- Study dates
- 4 Aug 2026to 28 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants must be ≥ 18 years of age at Screening
- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
- Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- Participants must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] < 50% above or below the normal limits of the central laboratory) at Screening.
- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
Who cannot join
- Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.
- Corneal decompensation unresponsive to medical management.
- Previous orbital irradiation or orbital surgery in either eye.
- Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening.
- Prior IGF-1R inhibitor therapy for any condition.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Asheville Clinical Trials
Asheville, North Carolina, 28803
Kaitlyn Cobb, 828-579-2273, KCOBB@ASHEVILLECLINICALTRIALS.COM
- Recruiting
Thrive Health Research LLC
Beverly Hills, California, 90210
Tasnim Sazzad, 310 299-6173, taz@thrivehealthiv.com
- Recruiting
Alliance Research Institute
Canoga Park, California, 91304
Pezhman Nazemi, 818-835-9085, pnazemi@allianceri.org
- Recruiting
Florida International Medical Research
Coral Gables, Florida, 33140
Lesner Suncin, 855-500-3467, lsuncin.fimresearch@gmail.com
- Recruiting
Ophthalmic Consultants of Boston, Inc
East Weymouth, Massachusetts, 02189
Mia Forsyth, 617-314-2732, mforsyth@eyeboston.com
- Recruiting
Sun City Clinical Research
Glendale, Arizona, 23502
Rohit Dwivedi, 623-253-9777, rdwivedi@suncitytrials.com
- Recruiting
Gulf Coast Clinical Trials
Houston, Texas, 77070
Viet Ta, 281-640-2940, vta@gulfcoasttrials.com
- Recruiting
Rovia Clinical Research at Florida Eye Specialists
Jacksonville, Florida, 32216
Ana Hungerford, 904-740-3940, ana.hungerford@roviaclinical.com
- Recruiting
Advancing Research International
Las Vegas, Nevada, 89144
Janelle Gonzalez, 323-877-7951, Janelle@ariclinicaltrials.com
- Recruiting
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, 48152
Kristin Brilla, 248-800-1180, kristin@mioculoplastics.com
- Recruiting
WVU Eye Institute
Morgantown, West Virginia, 26506
Emalee Taylor, 304-598-6135, emalee.taylor@wvumedicine.org
- Not yet recruiting
Columbia University Ophthalmology
New York, New York, 10022
Lora Glass, 212-305-9535, ld2514@cumc.columbia.edu
- Recruiting
Virginia Eye Consultants
Norfolk, Virginia, 23502
Alexandria Woods, 757-974-9988, alexandriawoods@cvphealth.com
- Recruiting
Pasadena Clinical Trials
Pasadena, California, 91101
Yaeji Choi, 626-822-6554, ychoi@pasadenatrials.com
- Recruiting
Vector Clinical Trials
Reno, Nevada, 89511
Sylvia Phillips, 775-877-9777, Sylviap@vectorclinicaltrials.com
- Recruiting
Silkiss Eye Surgery
San Francisco, California, 94102
Tiara Yamamoto, 424-262-1199, Tiara@ariclinicaltrials.com
- Recruiting
Advancing Research International, LLC
Santa Monica, California, 90404
Loisa Kalasa, 310-569-6076, Loisa@ariclinicaltrials.com
- Recruiting
The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey, 08873
Laila Imtiaz, 609-608-0142, laila@centerfacialplastics.com
About this study
Official title: A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).
- Conditions
- Thyroid Eye Disease, TED, Graves Orbitopathy
- Being tested
- linsitinib, Placebo
- Keywords
- Thyroid Eye Disease, TED, Graves Orbitopathy, Graves' Disease, Hashimoto's thyroiditis
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linsitinibDrug
150 mg linsitinib is taken twice daily by mouth for 24 weeks
PlaceboDrug
0 mg placebo taken twice daily by mouth for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Double-mask Treatment Arm | Experimental | Participants receive linsitinib 150 mg twice daily for 24 weeks. Receives: Drug: linsitinib |
| Double-mask Placebo Arm | Placebo comparator | Participants receive placebo 0 mg twice daily for 24 weeks. Receives: Drug: Placebo |
| Open-label Extension Treatment Arm | Experimental | Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks. Receives: Drug: linsitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure percentage of participants who are Proptosis Responders at Week 24
The proptosis responder rate is the percentage of participants with a ≥ 2 mm reduction of proptosis from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Measured: 24 weeks
Secondary outcomes (4)
Mean change from Baseline in Proptosis to Week 24
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.
Measured: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24
Overall responder rate (percentage of participants with ≥ 2-point reduction in 7 point CAS and ≥ 2 mm reduction in proptosis from Baseline in the primary study eye), provided there is no corresponding deterioration (≥ 2-point/mm increase) in CAS or proptosis in the contralateral non-study eye at Week 24.
Measured: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score.
Mean change from Baseline to Week 24 in the Graves' Orbitopathy Quality of Life questionnaire (GO-QoL) questionnaire overall score (0-100 where higher scores are a better outcome).
Measured: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start4 Aug 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion28 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sling Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753603
- Sponsor's protocol ID
- SLG-TED-303
- Acronym
- ORBIT
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
- ClinicalTrials.gov ID
- NCT07753603
- Acronym / sponsor ID
- ORBIT / SLG-TED-303
- Conditions
- Thyroid Eye Disease, TED, Graves Orbitopathy
- Keywords
- Thyroid Eye Disease, TED, Graves Orbitopathy, Graves' Disease, Hashimoto's thyroiditis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sling Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 28 Jun 2030 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-mask Treatment Arm | Experimental | Drug: linsitinibParticipants receive linsitinib 150 mg twice daily for 24 weeks. |
| Double-mask Placebo Arm | Placebo comparator | Drug: PlaceboParticipants receive placebo 0 mg twice daily for 24 weeks. |
| Open-label Extension Treatment Arm | Experimental | Drug: linsitinibProptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be ≥ 18 years of age at Screening
- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
- Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- Participants must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] < 50% above or below the normal limits of the central laboratory) at Screening.
- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
Key exclusion criteria (5 listed)
- Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.
- Corneal decompensation unresponsive to medical management.
- Previous orbital irradiation or orbital surgery in either eye.
- Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening.
- Prior IGF-1R inhibitor therapy for any condition.
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 |
|---|---|---|
| linsitinib150 mg linsitinib is taken twice daily by mouth for 24 weeks | Drug | Double-mask Treatment Arm, Open-label Extension Treatment Arm |
| Placebo0 mg placebo taken twice daily by mouth for 24 weeks | Drug | Double-mask Placebo Arm |
Primary outcome
Measure percentage of participants who are Proptosis Responders at Week 24
Time frame: 24 weeks
The proptosis responder rate is the percentage of participants with a ≥ 2 mm reduction of proptosis from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
4 secondary outcomes
Mean change from Baseline in Proptosis to Week 24
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score.
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing linsitinib in people with Thyroid Eye Disease, TED and Graves Orbitopathy, run by Sling Therapeutics, Inc. at 18 sites in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Radovich ((734) 223-1786, cathy.radovich@slingtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure percentage of participants who are Proptosis Responders at Week 24 (time frame: 24 weeks). 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.