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
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).
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 →Sling Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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 ↗
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Studies of the drug tested here: Linsitinib
Sling Therapeutics, Inc.