Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Sling Therapeutics, Inc. · NCT07753603
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 130
- US sites recruiting
- 17
- Study start
- August 4, 2026
- Record last updated
- October 20, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: linsitinib; Placebo
Conditions: Thyroid Eye Disease, TED; Graves Orbitopathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- Previous orbital irradiation or orbital surgery in either eye.
- 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.
- Prior IGF-1R inhibitor therapy for any condition.
Recruiting US locations
Sun City Clinical Research
Glendale, AZ 23502
Site contact: Rohit Dwivedi · 623-253-9777 · rdwivedi@suncitytrials.com
Thrive Health Research LLC
Beverly Hills, CA 90210
Site contact: Tasnim Sazzad · 310 299-6173 · taz@thrivehealthiv.com
Alliance Research Institute
Canoga Park, CA 91304
Site contact: Pezhman Nazemi · 818-835-9085 · pnazemi@allianceri.org
Pasadena Clinical Trials
Pasadena, CA 91101
Site contact: Yaeji Choi · 626-822-6554 · ychoi@pasadenatrials.com
Silkiss Eye Surgery
San Francisco, CA 94102
Site contact: Tiara Yamamoto · 424-262-1199 · Tiara@ariclinicaltrials.com
Advancing Research International, LLC
Santa Monica, CA 90404
Site contact: Loisa Kalasa · 310-569-6076 · Loisa@ariclinicaltrials.com
Florida International Medical Research
Coral Gables, FL 33140
Site contact: Lesner Suncin · 855-500-3467 · lsuncin.fimresearch@gmail.com
Rovia Clinical Research at Florida Eye Specialists
Jacksonville, FL 32216
Site contact: Ana Hungerford · 904-740-3940 · ana.hungerford@roviaclinical.com
Ophthalmic Consultants of Boston, Inc
East Weymouth, MA 02189
Site contact: Mia Forsyth · 617-314-2732 · mforsyth@eyeboston.com
Kahana Oculoplastic & Orbital Surgery
Livonia, MI 48152
Site contact: Kristin Brilla · 248-800-1180 · kristin@mioculoplastics.com
Advancing Research International
Las Vegas, NV 89144
Site contact: Janelle Gonzalez · 323-877-7951 · Janelle@ariclinicaltrials.com
Vector Clinical Trials
Reno, NV 89511
Site contact: Sylvia Phillips · 775-877-9777 · Sylviap@vectorclinicaltrials.com
The Center for Eye and Facial Plastic Surgery
Somerset, NJ 08873
Site contact: Laila Imtiaz · 609-608-0142 · laila@centerfacialplastics.com
Asheville Clinical Trials
Asheville, NC 28803
Site contact: Kaitlyn Cobb · 828-579-2273 · KCOBB@ASHEVILLECLINICALTRIALS.COM
Gulf Coast Clinical Trials
Houston, TX 77070
Site contact: Viet Ta · 281-640-2940 · vta@gulfcoasttrials.com
Virginia Eye Consultants
Norfolk, VA 23502
Site contact: Alexandria Woods · 757-974-9988 · alexandriawoods@cvphealth.com
WVU Eye Institute
Morgantown, WV 26506
Site contact: Emalee Taylor · 304-598-6135 · emalee.taylor@wvumedicine.org
Study contacts (from the official record)
- Cathy Radovich · (734) 223-1786 · cathy.radovich@slingtx.com