Can a pill reverse eye bulging in thyroid eye disease?
NCT ID NCT07753603
First seen Aug 07, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This clinical trial tests whether an oral medication called linsitinib can reduce eye bulging (proptosis) in people with moderate to severe active thyroid eye disease (TED). Participants will take either linsitinib or a placebo twice daily for 24 weeks. The main goal is to see if more people taking linsitinib achieve a meaningful reduction in eye bulging compared to those on placebo. The study also monitors safety and other effects on eye symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- linsitinib
- What this could lead to
- If successful, linsitinib could become a new oral treatment to reduce eye bulging and improve quality of life for people with thyroid eye disease.
- What could go wrong
- This is a phase 3 trial, but results are not guaranteed. The drug may not outperform placebo, and side effects are possible. The study is relatively small (130 participants), which may limit generalizability.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advancing Research International
RECRUITINGLas Vegas, Nevada, 89144, United States
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- New drug aims to ease bulging eyes in thyroid disease patients
- New drug MHB018A aims to reduce eye bulging in thyroid eye disease