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Can a pill tame thyroid eye disease?

NCT ID NCT05276063

Disease control Sponsor: Sling Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether an oral medication called linsitinib can help people with active, moderate to severe thyroid eye disease, a condition that causes eye bulging and inflammation. Participants take either linsitinib or a placebo twice daily for 24 weeks. The main goal is to see if the drug reduces eye bulging by at least 2 millimeters without worsening in the other eye.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linsitinib, an oral drug that blocks a specific protein (IGF-1R) involved in thyroid eye disease
What this could lead to
If successful, linsitinib could offer a convenient pill-based treatment to reduce eye bulging and inflammation in thyroid eye disease, potentially replacing or supplementing current therapies.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not hold up in larger studies. The drug may also cause side effects or fail to show significant benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

90 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline * Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia. * 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 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: * Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months. * Corneal decompensation unresponsive to medical management. * Previous orbital irradiation or orbital surgery. * Any glucocorticoid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to \>= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening. * Prior IGF-1R inhibitor therapy for any condition.

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Conditions

The condition(s) this trial relates to.

disease of orbital part of eye adnexa endocrine exophthalmos endocrine system disorder exophthalmos eye disorder Graves Ophthalmopathy Hashimoto thyroiditis thyroid gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endocrine system diseases Exophthalmos Eye diseases Graves ophthalmopathy Graves orbitopathy Hashimoto IGF1R Orbital diseases Proptosis Thyroid associated ophthalmopathy Thyroid diseases Thyroid eye disease

Contacts and locations

Locations

  • AOU Pisana

    Pisa, Italy

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136, United States

  • Byers Eye Institute - Stanford University

    Palo Alto, California, 94303, United States

  • Cardiff University

    Cardiff, CF14 4XN, United Kingdom

  • Center for Excellence in Eye Care

    Miami, Florida, 33176, United States

  • Chicago Oculofacial Plastic Surgery

    Chicago, Illinois, 60614, United States

  • Columbia University

    New York, New York, 10032, United States

  • Eyelid Center of Utah

    Salt Lake City, Utah, 84102, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Endocrinology Pawilione Zonda

    Milan, Italy

  • Frimley Health Foundation Trust

    Camberley, GU16 7UJ, United Kingdom

  • Hospital La Princesa

    Madrid, 28006, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08907, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Kellogg Eye Center

    Ann Arbor, Michigan, 48105, United States

  • Mass Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Moorfields Eye Hospital NIHR Clinical Research Facility

    London, EC1V 2PD, United Kingdom

  • Neuro-Eye Clinical Trials, Inc.

    Bellaire, Texas, 77401, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Thrive Health Research

    Beverly Hills, California, 90210, United States

  • Toronto Retina Institute

    North York, M3C 0G9, Canada

  • UC San Diego Health

    La Jolla, California, 92093, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • University of Pisa

    Pisa, Italy

  • Vancouver Coastal Health Eye Care Center

    Vancouver, British Columbia, V5Z 3N9, Canada

  • Wake Forest Baptist Health Eye Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington University in St. Louis/Barnes Jewish Hospital

    Creve Coeur, Missouri, 63141, United States

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

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