Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 3

Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

NCT07753603 · tracked via the Priya Life Science USA tracker
Sponsor
Sling Therapeutics, Inc
Phase
Phase 3
Started
2026-08-04
Last updated
2026-10-20

Condition(s) studied

Thyroid Eye Disease, TEDGraves Orbitopathy

Investigational drug(s) / intervention(s)

linsitinib →Placebo

linsitinib: 150 mg linsitinib is taken twice daily by mouth for 24 weeks

Placebo: 0 mg placebo taken twice daily by mouth for 24 weeks

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participants must be ≥ 18 years of age at Screening 2. 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. 3. 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. 4. 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. 5. 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. Exclusion Criteria: 1. Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator. 2. Corneal decompensation unresponsive to medical management. 3. Previous orbital irradiation or orbital surgery in either eye. 4. 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. 5. Prior IGF-1R inhibitor therapy for any condition.

Primary outcome measure(s)

  • Measure percentage of participants who are Proptosis Responders at Week 24 — 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.

Trial sites (18)

FacilityCityRegionStatus
Sun City Clinical Research Glendale Arizona Recruiting
Thrive Health Research LLC Beverly Hills California Recruiting
Alliance Research Institute Canoga Park California Recruiting
Pasadena Clinical Trials Pasadena California Recruiting
Silkiss Eye Surgery San Francisco California Recruiting
Advancing Research International, LLC Santa Monica California Recruiting
Florida International Medical Research Coral Gables Florida Recruiting
Rovia Clinical Research at Florida Eye Specialists Jacksonville Florida Recruiting
Ophthalmic Consultants of Boston, Inc East Weymouth Massachusetts Recruiting
Kahana Oculoplastic & Orbital Surgery Livonia Michigan Recruiting
Advancing Research International Las Vegas Nevada Recruiting
Vector Clinical Trials Reno Nevada Recruiting
The Center for Eye and Facial Plastic Surgery Somerset New Jersey Recruiting
Columbia University Ophthalmology New York New York Not Yet Recruiting
Asheville Clinical Trials Asheville North Carolina Recruiting
Gulf Coast Clinical Trials Houston Texas Recruiting
Virginia Eye Consultants Norfolk Virginia Recruiting
WVU Eye Institute Morgantown West Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753603 on ClinicalTrials.gov ↗ ← All trials in the USA