Could a cholesterol drug shrink eye muscle swelling in thyroid eye disease?
NCT ID NCT07762105
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether adding atorvastatin, a common cholesterol-lowering drug, to the standard steroid treatment can better reduce eye muscle swelling in people with moderate-to-severe thyroid eye disease. Half of the participants will receive the standard steroid alone, while the other half will also take atorvastatin daily for 24 weeks. The study will measure changes in eye muscle size using CT scans and look at certain biological markers to see if the combination therapy is more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atorvastatin (a cholesterol-lowering drug) added to standard intravenous methylprednisolone (a steroid)
- What this could lead to
- If it works, adding atorvastatin to standard steroid treatment could offer a more effective way to reduce eye muscle swelling and improve symptoms in thyroid eye disease.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The benefit of atorvastatin for this condition is unproven, and it may not work as hoped.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 64 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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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 75 years
- 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: * Age 18 to 75 years inclusive * Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria * Active disease, clinical activity score ≥ 3 of 7 * Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds * Able to attend weekly infusion visits and complete follow-up to week 48 * Written informed consent given * For women of childbearing potential, agreement to use effective contraception until week 24 Exclusion Criteria: * Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown * Any other autoimmune disease requiring systemic immunosuppresion * Known hypersensitivity to atorvastatin or to any statin * Current or recent (within 3 months) use of any lipid-lowering drug * Any contraindication to orbital decompression * Any independent indication for lipid-lowering therapy: established atherosclerotic cardiovascular disease, more than one cardiovascular risk factor (diabetes mellitus, hypertension, obesity), or LDL cholesterol ≥ 190 mg/dL * Systemic glucocorticoid or immunosuppressive treatment for orbitopathy within the preceding 3 months * Previous orbital irradiation or orbital surgery * Alanine or aspartate aminotransferase \> 3 × upper limit of normal, or creatine kinase \> 5 × upper limit of normal, at screening * Estimated glomerular filtration rate \< 30 mL/min/1.73 m² * Pregnancy at screening (confirmed by a negative test before randomisation) or breastfeeding * Concomitant treatment with a strong CYP3A4 inhibitor * Any condition that, in the opinion of the investigator, would prevent completion of the trial
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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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Universitas Gadjah Mada
Yogyakarta, Yogyakarta, Indonesia, Indonesia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill tame thyroid eye disease?
- Can a targeted antibody calm thyroid eye disease?
- Can a pill reverse eye bulging in thyroid eye disease?
- Can an experimental drug reduce eye bulging in thyroid eye disease?
- Can a new drug ease bulging eyes in thyroid disease?