Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Linsitinib for people with active thyroid eye disease
Tests linsitinib in adults with active thyroid eye disease.
Key facts
- Who runs it
- Sling Therapeutics, Inc.
- Where
- Asheville, Beverly Hills, Canoga Park, Coral Gables, East Weymouth, Glendale, Houston, Jacksonville, Las Vegas, Livonia, Morgantown, New York, Norfolk, Pasadena, Reno, San Francisco, Santa Monica, and Somerset, United StatesSee the 18 sites
- Trial code
- Registry title
- Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 130 people, planned
- Started
- 4 Aug 2026
- Expected to end
- 28 Jun 2030
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- linsitinib
- Placebo
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active thyroid eye disease (TED) of moderate to severe level. It tests linsitinib against a placebo (dummy pill).
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Active moderate to severe TED linked to Graves' disease and/or Hashimoto's thyroiditis. CAS (eye inflammation score) ≥ 3 on the 7-item scale in the worse eye. TED diagnosed within 15 months before screening. Not sight-threatening. Thyroid levels normal or only mildly off (FT4 and FT3 < 50% above or below normal limits).
- Earlier treatment
- No previous radiation or surgery to the eye socket in either eye. No IGF-1R inhibitor therapy ever. No glucocorticoids (IV or oral) totalling ≥ 1 g methylprednisolone or equivalent for TED within 8 weeks of screening.
Main reasons for not taking part
- Optic nerve damage from TED that has worsened in the last 6 months
- Damage to the clear front of the eye (cornea) not helped by medicine
- Needing eye surgery, eye socket radiation or other eye treatment now, or planning it during the study
- Previous radiation or surgery to the eye socket
- Prior IGF-1R inhibitor therapy for any condition
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Participants must be ≥ 18 years of age at Screening
- 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
- 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
- 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
- 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
Who cannot take part
- Previous orbital irradiation or orbital surgery in either eye
- Prior IGF-1R inhibitor therapy for any condition
- Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator
- Corneal decompensation unresponsive to medical management
- 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
Where in United States
- Asheville Clinical TrialsAsheville, United StatesContact: Kaitlyn CobbTaking people
- Thrive Health Research LLCBeverly Hills, United StatesContact: Tasnim SazzadTaking people
- Alliance Research InstituteCanoga Park, United StatesContact: Pezhman NazemiTaking people
- Florida International Medical ResearchCoral Gables, United StatesContact: Lesner SuncinTaking people
- Ophthalmic Consultants of Boston, IncEast Weymouth, United StatesContact: Mia ForsythTaking people
- Sun City Clinical ResearchGlendale, United StatesContact: Rohit DwivediTaking people
- Gulf Coast Clinical TrialsHouston, United StatesContact: Viet TaTaking people
- Rovia Clinical Research at Florida Eye SpecialistsJacksonville, United StatesContact: Ana HungerfordTaking people
- Advancing Research InternationalLas Vegas, United StatesContact: Janelle GonzalezTaking people
- Kahana Oculoplastic & Orbital SurgeryLivonia, United StatesContact: Kristin BrillaTaking people
- WVU Eye InstituteMorgantown, United StatesContact: Emalee TaylorTaking people
- Columbia University OphthalmologyNew York, United StatesContact: Lora GlassNot yet recruiting
- Virginia Eye ConsultantsNorfolk, United StatesContact: Alexandria WoodsTaking people
- Pasadena Clinical TrialsPasadena, United StatesContact: Yaeji ChoiTaking people
- Vector Clinical TrialsReno, United StatesContact: Sylvia PhillipsTaking people
- Silkiss Eye SurgerySan Francisco, United StatesContact: Tiara YamamotoTaking people
- Advancing Research International, LLCSanta Monica, United StatesContact: Loisa KalasaTaking people
- The Center for Eye and Facial Plastic SurgerySomerset, United StatesContact: Laila ImtiazTaking people
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- Double-mask Treatment ArmTreatment being tested
Participants receive linsitinib 150 mg twice daily for 24 weeks.
Treatment: linsitinib
- Double-mask Placebo ArmPlacebo, for comparison
Participants receive placebo 0 mg twice daily for 24 weeks.
Treatment: Placebo
- Open-label Extension Treatment ArmTreatment being tested
Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks.
Treatment: linsitinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Linsitinib for people with active thyroid eye diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 20 October 2026