Evaluating linsitinib for thyroid eye disease
Official title: A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Run by Sling Therapeutics, Inc. · NCT06112340 · Data updated 2026-11-12
This study is testing if a new drug called linsitinib can help people with moderate to severe thyroid eye disease who haven't improved with other treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Sling Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | linsitinib |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | October 11, 2023 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT06112340 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who completed a previous study and are either non-responders or relapsed patients with controlled thyroid conditions.
✕Probably not a fit
Patients who require immediate ophthalmic surgery or have uncontrolled thyroid conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in patients with active, moderate to severe thyroid eye disease who did not respond to previous treatment or experienced a relapse. Participants must have completed a prior study and meet specific criteria regarding their thyroid condition. The study will involve administering two doses of linsitinib to eligible subjects and monitoring their responses over time.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved outcomes for patients suffering from thyroid eye disease.
How similar studies have gone: Previous studies have shown varying success with treatments for thyroid eye disease, but this specific approach with linsitinib is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301 * Subject has not received any treatment for TED since Week 24 of VGN-TED-301 * Subjects 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) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial * Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study Exclusion Criteria: * The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.
Where it's running
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Bascom Palmer Eye Institute
Miami, Florida, United States Recruiting -
West Virginia University Eye Institute
Morgantown, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Cathy Radovich
- Email: info@slingtx.com
- Phone: 734-887-9192
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ETHY-001 safety and activity in Thyroid Eye Disease (TED)
This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.
-
Linsitinib in moderate to severe Thyroid Eye Disease (TED)
This study tests whether linsitinib can help people with moderate to severe TED associated with Graves' disease or Hashimoto's thyroiditis.
-
Tofacitinib for steroid‑resistant moderate-to-severe thyroid eye disease
This will test whether taking oral tofacitinib (5 mg twice daily) for 24 weeks can reduce eye bulging and inflammation in adults with moderate-to-severe thyroid eye disease who don't respond to or cannot take high-dose steroids.
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Teprotumumab for treating thyroid eye disease and thyroid dysfunction
This study is testing how well teprotumumab can help people with thyroid eye disease who have serious symptoms like bulging eyes, pain, and double vision.
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Treatment for Graves' ophthalmopathy using simvastatin
This study is testing if simvastatin can help people with mild to moderate Graves' ophthalmopathy avoid getting worse.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.