A Phase 2 interventional study of Atorvastatin in Graves Disease, Graves Disease (Basedow's Disease) and Graves Orbitopathy, sponsored by Region Skane. Not yet recruiting at 7 sites in Sweden. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Region Skane · Phase 2, Interventional, and Prevention
Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye discomfort, double vision, changes in appearance, and, in severe cases, problems with vision.
The purpose of this study is to find out whether atorvastatin, a commonly used cholesterol-lowering medicine, can reduce the risk of developing active thyroid eye disease in adults who have recently been diagnosed with Graves' disease.
A total of 554 participants will be randomly assigned to one of two groups. One group will receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for Graves' disease. The other group will receive standard treatment for Graves' disease alone. Participants will be followed for 18 months.
During the study, participants will have regular assessments of their thyroid disease and their eyes. Blood samples and questionnaires about symptoms and quality of life will also be collected. The researchers will compare the two groups to determine whether atorvastatin reduces the development of active thyroid eye disease.
Graves' disease (GD) is an autoimmune thyroid disorder in which stimulating antibodies against the thyrotropin receptor cause hyperthyroidism. Graves' orbitopathy (GO), also referred to as thyroid eye disease, is the most important extrathyroidal manifestation of GD. GO may cause pain, swelling, redness, proptosis, diplopia, impaired quality of life, and, in severe cases, visual impairment. Although treatment of established GO has improved, there are currently limited options for preventing the development of GO in patients with newly diagnosed GD.
Observational studies have suggested that treatment with statins may be associated with a lower risk of developing GO in patients with GD. Statins have anti-inflammatory and immunomodulatory effects in addition to their lipid-lowering properties, providing a biological rationale for evaluating whether statin treatment can prevent GO. However, the preventive effect of statins has not been established in a sufficiently large randomized controlled trial.
ATORGO is a multicenter, randomized, controlled clinical trial designed to evaluate whether treatment with atorvastatin reduces the risk of developing active GO in adults with newly diagnosed GD. Participants are randomized in a 1:1 ratio to receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for GD, or standard treatment for GD alone.
Participants are followed for 18 months after randomization. Clinical assessments are performed at predefined study visits and include evaluation of thyroid disease and signs and symptoms of GO. Eye assessments include standardized documentation of clinical findings and photographs. To reduce the risk of assessment bias, relevant ophthalmic outcomes are evaluated by assessors who are blinded to treatment allocation using standardized photographic documentation where applicable.
Blood samples are collected during follow-up to assess thyroid function, thyrotropin receptor antibodies, and other study-related biomarkers. Patient-reported outcomes are assessed using validated questionnaires addressing thyroid-related and GO-related symptoms and quality of life.
The main objective is to determine whether adding atorvastatin to standard GD treatment reduces the development of active GO compared with standard GD treatment alone. Additional analyses will evaluate the timing and severity of GO, the need for GO-specific treatment, changes in thyroid autoimmunity, patient-reported outcomes, and potential biological markers associated with the development of GO or response to treatment.
The study is intended to provide evidence on whether a widely available, inexpensive, and well-established medication can be repurposed to prevent GO in patients with newly diagnosed GD.
156 studies on the registry are indexed under Graves Disease; 54 are open to participants now.
This study's planned enrollment of 554 is above the median of 60 across 97 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Region Skane is the lead sponsor of 382 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive standard treatment for Graves' disease according to current clinical practice, without study treatment with atorvastatin. Standard care may include antithyroid drugs and other clinically indicated treatment.
Participants receive atorvastatin 40 mg orally once daily for 12 months in addition to standard treatment for Graves' disease. Standard treatment for Graves' disease is provided according to current clinical practice and may include antithyroid drugs and other clinically indicated treatment.
Drug: Atorvastatin
Atorvastatin 40 mg is administered orally once daily for 12 months, in addition to standard treatment for Graves' disease.
Development of Active Graves' Orbitopathy
Proportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
Time frame: 12 months after randomization
Development of Active Graves' Orbitopathy at 3, 6, 9, 15, and 18 Months
Proportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
Time frame: 3, 6, 9, 15, and 18 months after randomization
Genetic Factors Associated With Response to Atorvastatin
Genotype frequencies for CYR61 rs3753793 and rs12756618, ZFP36 rs1057745, SCD rs1393491, CTLA4 rs231775, TSHR rs179247, and SLCO1B1 rs4149056 will be determined. Genotype frequencies will be compared between participants with and without active Graves' ophthalmopathy, defined as a Clinical Activity Score (CAS) ≥3 at 12 months.
Time frame: Baseline (genotyping) and 12 months (CAS)
Time to Development of Active Graves' Orbitopathy
Time from GD diagnosis to the first occurrence of active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3.
Time frame: From diagnosis through 18 months
Correlations between circulating biomarker levels and Graves' ophthalmopathy clinical activity score
Spearman's rank correlation coefficients will be calculated separately for each circulating biomarker and the seven-item Clinical Activity Score (CAS) at each visit. The biomarker panel comprises multimerin-1 (MMRN1), IgG Fc-binding protein (FCGBP), cadherin-5 (CDH5), complement factor H-related protein 5 (CFHR5), apolipoprotein D (APOD), C-X-C motif chemokine ligand 10 (CXCL10/IP-10), and interleukin-6 (IL-6). These analyses are exploratory.
Time frame: Baseline, 3 months, 12 months, and 18 months
Maximum Clinical Activity Score During Follow-up
The highest Clinical Activity Score (CAS) recorded for each participant during the study follow-up period. Higher scores indicate greater inflammatory activity of Graves' orbitopathy.
Time frame: From randomization through 18 months
Need for Treatment for Graves' Orbitopathy
Proportion of participants requiring treatment for Graves' orbitopathy, including systemic glucocorticoids, orbital radiotherapy, biologic treatment, or other disease-specific treatment because of development or progression of Graves' orbitopathy.
Time frame: From randomization through 18 months
Change in Graves' Orbitopathy-Specific Quality of Life
Change in Graves' orbitopathy-related quality of life assessed using the Graves' Orbitopathy Quality of Life questionnaire (GO-QoL). The questionnaire assesses visual functioning and appearance-related impact of Graves' orbitopathy.
Time frame: Baseline, 12 months, and 18 months
Change in Thyroid-Related Quality of Life
Change in thyroid-related symptoms and quality of life assessed using the ThyPRO questionnaire.
Time frame: Baseline, 12 months, and 18 months
Change in Thyrotropin Receptor Antibody Levels
Change in serum thyrotropin receptor antibody (TRAb) levels from baseline during follow-up.
Time frame: Baseline, 6, 12, 18 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2032, 72 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Atorvastatin