Clinical Trial

Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease

Study acronym: SEMAR-TED
Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07762105
Lead Sponsor Banu Aji Dibyasakti
Conditions Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy
Enrollment 64 participants
Start Date 2026-08-30
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13