Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moder… (NCT07762105) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease
Indonesia64 participantsStarted 2026-08-30
Plain-language summary
The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K/AKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \[26\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Individual rectus muscle diameters
Timeframe: At the first week,12th week, and 24th week from starting point of treatment