A Phase 3 interventional study of linsitinib and Placebo in Thyroid Eye Disease, TED and Graves Orbitopathy, sponsored by Sling Therapeutics, Inc.. Recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Sling Therapeutics, Inc. · Phase 3, Interventional, and Treatment
Among 53 studies in Graves Ophthalmopathy with a site in United States — 12 open to participants now, 18 under way, 8 of them phase 3. Graves Ophthalmopathy · United States.
Among the 53 studies in Graves Ophthalmopathy with a site in United States, this one is the 11th largest by planned enrollment of the 47 interventional ones, is one of 9 that started in 2026, is one of 21 in phase 3, reaches primary completion later than 12 of the 17 other live ones, and was the 51st registered.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 130 is above the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →12 of the 53 studies in Graves Ophthalmopathy with a site in United States are open now, in 5 countries. Each count lists the studies.
Of the 38 Graves Ophthalmopathy studies recruiting now, 8 (21%) set no upper age limit and 16 (42%) stop at 75 or younger; 1 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →53 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 9 started in 2026.
Median enrollment 84 across the 47 interventional studies, 100 across the 5 observational. Of the 33 that completed or were terminated, 17 (52%) have results posted.
42 of 53 have an industry lead sponsor. The 10 most frequent:
Sling Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Sling Therapeutics, Inc. has 3 studies filed under Graves Ophthalmopathy — fewer than ten, so there is no comparison to draw.
4 of the studies in Graves Ophthalmopathy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401044AmgenA Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease | 2027-01-06 |
| NCT07832136Viridian Therapeutics, Inc.An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab | 2027-04 |
| NCT07623837THYROSCOPE INC.Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM) | 2027-06-30 |
| NCT07623993THYROSCOPE INC.Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE) | 2027-06-30 |
Among the 53 studies in Graves Ophthalmopathy with a site in United States, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive linsitinib 150 mg twice daily for 24 weeks.
Drug: linsitinib
Participants receive placebo 0 mg twice daily for 24 weeks.
Drug: Placebo
Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks.
Drug: linsitinib
150 mg linsitinib is taken twice daily by mouth for 24 weeks
0 mg placebo taken twice daily by mouth for 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 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.
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.
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).
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.
Percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Time frame: 24 Weeks
To assess the safety and tolerability of linsitinib 150 mg twice daily as compared to placebo over a 24-week period.
Incidence of TEAEs (defined as AEs that begin or worsen after the first dose of study drug), treatment-emergent SAEs, deaths, discontinuation due to AEs, clinical safety laboratory results, vital signs, physical and ophthalmic examinations, and ECG parameters.
Time frame: 24 Weeks
Started Aug 2026 (actual). Primary completion is estimated for Jun 2028, 22 months after the start.
Of 29 phase 3 interventional studies under Graves Ophthalmopathy, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 25. This study's planned 22 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Linsitinib
Sling Therapeutics, Inc.