Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease
Key facts
- Who runs it
- Banu Aji Dibyasakti
- Where
- Yogyakarta, IndonesiaSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 1
- People taking part
- 64 people, planned
- Started
- 30 Aug 2026
- Expected to end
- 30 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Atorvastatin
- methylprednisolone (IVMP)
- Record updated
- 13 August 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current or recent (within 3 months) use of any lipid-lowering drug
- Previous orbital irradiation or orbital surgery
- Concomitant treatment with a strong CYP3A4 inhibitor
- 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
- Any condition that, in the opinion of the investigator, would prevent completion of the trial
- 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
- Any contraindication to orbital decompression
- Systemic glucocorticoid or immunosuppressive treatment for orbitopathy within the preceding 3 months
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Indonesia
- Universitas Gadjah MadaYogyakarta, IndonesiaContact: Banu Aji Dibyasakti, MDNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Methylprednisolone onlyExisting treatment, for comparison
Experimental group recieve methylprednisolone injection 500 mg per week for six weeks followed by methylprednisolone 250 mg per weeks for following six weeks
Treatment: methylprednisolone (IVMP)
- Methylprednisolone plus AtorvastatinTreatment being tested
Experimental group recieve methylprednisolone injection 500 mg per week for six weeks followed by methylprednisolone 250 mg combined per week for following six weeks combined atorvastatin 20 mg per weeks for six months
Treatment: Atorvastatin and methylprednisolone (IVMP)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Adjunctive Atorvastatin in Moderate-to-severe Thyroid Eye Disease (SEMAR-TED: Structural, Biomarker Expression and Muscle Endpoints of Atorvastatin): Study Protocol for a Randomised, Open-label, Assessor-masked Controlled Trial
- Fit questions
- Built from NCT07762105, who can take part
- Record updated
- 13 August 2026