[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sling Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100650794","phase-3-study-to-assess-linsitinib-in-participants-with-moderate-to-severe-active-thyroid-eye-disease-ted-100650794",false,"NCT07753603","Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)","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)","ORBIT","Inclusion Criteria:\n\n1. Participants must be ≥ 18 years of age at Screening\n2. Clinical diagnosis of Graves' Disease and\u002For 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.\n3. 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\u002For inconstant or constant diplopia.\n4. 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\\] \\\u003C 50% above or below the normal limits of the central laboratory) at Screening.\n5. 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.\n\nExclusion Criteria:\n\n1. Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.\n2. Corneal decompensation unresponsive to medical management.\n3. Previous orbital irradiation or orbital surgery in either eye.\n4. 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.\n5. Prior IGF-1R inhibitor therapy for any condition.","ALL","18 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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).",[27,28],"Thyroid Eye Disease, TED","Graves Orbitopathy",[30,31,28,32,33],"Thyroid Eye Disease","TED","Graves' Disease","Hashimoto's thyroiditis","RECRUITING","2026-08-07",{"date":37,"type":38},"2026-08-11","ACTUAL",{"date":40,"type":21},"2026-08-04",{"date":42,"type":21},"2030-06-28",{"name":44,"class":45},"Sling Therapeutics, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":5},"100524715","phase-2-extension-study-of-two-doses-of-linsitinib-in-subjects-with-active-moderate-to-severe-thyroid-eye-disease-ted-100524715","NCT06112340","Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","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)","Inclusion Criteria:\n\n* Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\\\u003C 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\n* Subject has not received any treatment for TED since Week 24 of VGN-TED-301\n* 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\\] \\\u003C50% 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\n* 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\n\nExclusion Criteria:\n\n* The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.",{"count":55,"type":21},75,[57,24],"PHASE2","The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.",[30,28,60,61,62,63,64,65,66,67,68,69],"Endocrine System Diseases","Eye Diseases","Thyroid Associated Ophthalmopathy","Graves Ophthalmopathy","Thyroid Diseases","Orbital Diseases","Proptosis","IGF1R","Exophthalmos","Hashimoto","2025-02-24",{"date":72,"type":38},"2025-02-25",{"date":74,"type":38},"2023-10-11",{"date":76,"type":21},"2026-06",{"name":44,"class":45},""]